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Big Data Analytics In M2M
WHITE PAPER
Medical Devices - Implementation of Unique Device Identification (UDI)
Big Data Analytics In M2M
WHITE PAPER
Hello, I'm from HCL's Engineering and R&D Services. We enable technology led organizations to go to market with innovative products and solutions. We partner with our customers in building world class products and creating associated solution delivery ecosystems to help bring market leadership. We develop engineering products, solutions and platforms across Aerospace and Defense, Automotive, Consumer Electronics, Software, Online, Industrial Manufacturing, Medical Devices, Networking & Telecom, Office Automation, Semiconductor and Servers & Storage for our customers. For more details contact: [email protected] Follow us on Twitter: http://twitter.com/hclers & LinkedIn: http://lnkd.in/bt8hDXM View our blog-site: http://www.hcltech.com/blogs/engineering-and-rd-services Visit our website: http://www.hcltech.com/engineering-rd-services
Table of Contents
Abstract ............................................................................................. 3
Abbreviations .................................................................................... 3
Glossary ............................................................................................. 3
Market Trends and Challenges ......................................................... 4
Scope ................................................................................................. 5
UDI Format ........................................................................................ 6
Technical Requirements.................................................................... 6
UDI Compliance Dates for Medical Devices ...................................... 8
UDI Implementation – Process Approach ......................................... 9
UDI Compliance in Warehouse Operations .................................... 10
GUDID Requirements ...................................................................... 11
GUDID Data Submission Methods .................................................. 12
HCL’s GUDID Data Submission Approach ....................................... 13
UDI Issuing Agencies ....................................................................... 13
General Exceptions ......................................................................... 14
Benefits of UDI Implementation ..................................................... 14
Conclusion ....................................................................................... 15
References ...................................................................................... 15
Hello, I'm from HCL's Engineering and R&D Services. We enable technology led organizations to go to market with innovative products and solutions. We partner with our customers in building world class products and creating associated solution delivery ecosystems to help bring market leadership. We develop engineering products, solutions and platforms across Aerospace and Defense, Automotive, Consumer Electronics, Software, Online, Industrial Manufacturing, Medical Devices, Networking & Telecom, Office Automation, Semiconductor and Servers & Storage for our customers. For more details contact: [email protected] Follow us on Twitter: http://twitter.com/hclers & LinkedIn: http://lnkd.in/bt8hDXM View our blog-site: http://www.hcltech.com/blogs/engineering-and-rd-services Visit our website: http://www.hcltech.com/engineering-rd-services
Abstract Unique Device Identification (UDI) is a new regulation from the U.S. FDA, which requires that the label
and device package of each medical device include a UDI. On September 24, 2013, the FDA published a
final rule (the UDI Rule), establishing the UDI system. U.S. FDA Code of Federal Regulation (CFR) parts
801.55, 830.10, 830.100, 830.110, 830.120, and 830.130 of the rule came into effect on October 24,
2013; the remaining parts came into effect on December 13, 2013.
As part of the UDI final rule, labelers of medical devices must submit information concerning their
devices to the Global Unique Device Identification Database (GUDID).
This paper is intended to provide information to the medical device industry concerning the FDA’s UDI
system, and gives an overview of HCL’s implementation of UDI processes for medical devices and the
corresponding business impact.
Abbreviations Sl. No Acronyms Full Form
1 AIDC Automatic Identification and Data Capture
2 GMDN Global Medical Device Nomenclature
3 GS1 Global Standards/Solutions
4 GUDID Global Unique Device Identification Database
5 HIBCC Health Industry Business Communications Council
6 ICCBBA International Council for Commonality in Blood Banking Automation
7 PHS Public Health Service
8 PMA Premarket Approval
9 RFID Radio-Frequency Identification
10 XML Extensible Markup Language
Glossary Device Identifier (DI): A mandatory, fixed portion of a UDI that identifies the specific version or model of
a device and the labeler of that device.
Global Unique Device Identification Database (GUDID): The database that serves as a repository of
information that facilitates the identification of medical devices through its distribution and use.
Labeler:
Hello, I'm from HCL's Engineering and R&D Services. We enable technology led organizations to go to market with innovative products and solutions. We partner with our customers in building world class products and creating associated solution delivery ecosystems to help bring market leadership. We develop engineering products, solutions and platforms across Aerospace and Defense, Automotive, Consumer Electronics, Software, Online, Industrial Manufacturing, Medical Devices, Networking & Telecom, Office Automation, Semiconductor and Servers & Storage for our customers. For more details contact: [email protected] Follow us on Twitter: http://twitter.com/hclers & LinkedIn: http://lnkd.in/bt8hDXM View our blog-site: http://www.hcltech.com/blogs/engineering-and-rd-services Visit our website: http://www.hcltech.com/engineering-rd-services
1. Any person who causes a label to be applied to a device with the intent that the device will be
commercially distributed without any intended subsequent replacement or modification of the
label; and
2. Any person who causes the label of a device to be replaced or modified with the intent that the
device will be commercially distributed without any subsequent replacement or modification of the
label, except that the addition of the name of, and contact information for, a person who distributes
the device, without making any other changes to the label, is not a modification for the purposes of
determining whether a person is a labeler.
Production Identifier (PI): A conditional, variable portion of a UDI that identifies one or more of the
following when included on the label of the device:
1. The lot or batch within which a device was manufactured
2. The serial number of a specific device
3. The expiry date of a specific device
4. The date when a specific device was manufactured
Unique Device Identifier (UDI): An identifier that adequately identifies a device through its distribution
and use by meeting the requirements of 21 CFR 830.20. A unique device identifier is composed of (1) a
device identifier, and (2) a production identifier.
Market Trends and Challenges Traceability is currently not regulated by the Medical Device Directives. The lack of unambiguous
identification of medical devices or the inaccessibility to critical device-related information, significantly
impacts the healthcare supply chain, patient safety, and treatment processes. The tracking mechanisms
for post market safety of medical devices due to incident reporting, recalls or adverse events, targeted
field safety corrective actions, and monitoring by competent authorities, are not efficient.
Therefore, the Food and Drug Administration Amendments Act (FDAAA) mandated the U.S. Food and
Drug Administration (FDA) to establish a unique device identification system which enables easy tracking
and identification of medical devices throughout their lifecycle i.e. from production through use in
clinical practice. The best way to ensure effective traceability of medical devices in the Union is to
develop a UDI system. The UDI will function as the key that can be used to obtain critical information
from the GUDID about the medical devices. It will allow the FDA, health care providers, and industries to
more rapidly extract useful information and effectively monitor the devices in the market.
Hello, I'm from HCL's Engineering and R&D Services. We enable technology led organizations to go to market with innovative products and solutions. We partner with our customers in building world class products and creating associated solution delivery ecosystems to help bring market leadership. We develop engineering products, solutions and platforms across Aerospace and Defense, Automotive, Consumer Electronics, Software, Online, Industrial Manufacturing, Medical Devices, Networking & Telecom, Office Automation, Semiconductor and Servers & Storage for our customers. For more details contact: [email protected] Follow us on Twitter: http://twitter.com/hclers & LinkedIn: http://lnkd.in/bt8hDXM View our blog-site: http://www.hcltech.com/blogs/engineering-and-rd-services Visit our website: http://www.hcltech.com/engineering-rd-services
The Results of UDI Non-Compliance
Here are a few complaints impacting patient safety due to a lack of data traceability.
Figure 1: Issues faced due to lack of device traceability
Scope
UDI applies to the devices and their accessories, as illustrated below:
• Medical Devices – these are instruments, apparatus, implants, in vitro reagents, and similar or
related articles that are used to diagnose, prevent, or treat disease or other conditions, and do not
achieve their purposes through chemical action within or on the body.
• Active Implantable Medical Devices – are active medical devices that are intended to be totally or
partially introduced, surgically or medically, into the human body or by medical intervention into a
natural orifice, and that are intended to remain there, after the procedure
• In Vitro Diagnostic Medical Devices – are devices, whether used alone or in combination, intended
by the manufacturer for the in-vitro examination of specimens derived from the human body solely
or principally to provide information for diagnostics, monitoring, or compatibility purposes. These
include reagents, calibrators, control materials, specimen receptacles, software, and related
instruments or apparatus or other articles.
A UDI must also be placed directly on devices (but not on all implants) that are likely to be separated
from their label over time, such as:
Adverseevents-2007
66,000
60% lacked product identifier
25% wrong manufacturer name
10% No product brand name
US Defense department findings in product brochures
HIP replacement system Recall tracking
Hello, I'm from HCL's Engineering and R&D Services. We enable technology led organizations to go to market with innovative products and solutions. We partner with our customers in building world class products and creating associated solution delivery ecosystems to help bring market leadership. We develop engineering products, solutions and platforms across Aerospace and Defense, Automotive, Consumer Electronics, Software, Online, Industrial Manufacturing, Medical Devices, Networking & Telecom, Office Automation, Semiconductor and Servers & Storage for our customers. For more details contact: [email protected] Follow us on Twitter: http://twitter.com/hclers & LinkedIn: http://lnkd.in/bt8hDXM View our blog-site: http://www.hcltech.com/blogs/engineering-and-rd-services Visit our website: http://www.hcltech.com/engineering-rd-services
• Implantable devices (>30 days)
• Devices intended to be used more than once and are sterilized before each use
• Stand-alone software
UDI Format There are very specific technical requirements for UDIs. FDA-accredited Issuing Agencies (IAs) are
required to issue UDIs that conform to the following ISO standards from which the UDI format is derived.
• ISO/IEC 646:1991 - Information technology -- ISO 7-bit coded character set for information
interchange.
• ISO/IEC 15459-2:2006(E) - Information technology -- Unique identifiers -- Part 2: Registration
procedures.
• ISO/IEC 15459-4:2008 - Information technology -- Unique identifiers -- Part 4: Individual items.
• ISO/IEC 15459-6:2007 - Information technology -- Unique identifiers -- Part 6: Unique identifier for
product groupings.
Technical Requirements A. Representation
UDI should appear in both human readable format (human readable version composed of a series of
numeric or alpha numeric characters) and in a format that can be read by an AIDC technology.
Automatic Identification and Data Capture (AIDC) technology: The most commonly used identification
data capture technology is Barcode and RFID.
Barcode has two forms: One dimensional (1D – linear stacked, linear concatenated) and Two
dimensional (2D – square data matrix) barcode.
1D Linear stacked barcode has the DI and PI barcodes on separate lines
1D Concatenated version joins the DI and PI together into one long barcode
2D Data matrix blends the DI and PI together into one image
Types of Barcodes Linear stacked Linear – Concatenated 2D Data Matrix
(00) 0 546465 431612345 4 (01) 0 546465 43 (16) 12345
(01) 2 56602198 097 5
(19) 4654316(20)1Q25
Hello, I'm from HCL's Engineering and R&D Services. We enable technology led organizations to go to market with innovative products and solutions. We partner with our customers in building world class products and creating associated solution delivery ecosystems to help bring market leadership. We develop engineering products, solutions and platforms across Aerospace and Defense, Automotive, Consumer Electronics, Software, Online, Industrial Manufacturing, Medical Devices, Networking & Telecom, Office Automation, Semiconductor and Servers & Storage for our customers. For more details contact: [email protected] Follow us on Twitter: http://twitter.com/hclers & LinkedIn: http://lnkd.in/bt8hDXM View our blog-site: http://www.hcltech.com/blogs/engineering-and-rd-services Visit our website: http://www.hcltech.com/engineering-rd-services
Examples of UDI
Figure 2: Illustrated Medical Device UDI label. This is for illustration purposes only.
B. UDI Elements
The final rule establishes requirements for the UDI that must appear on each label. Typically, UDI is
composed of two parts:
Unique Device Identifier (UDI) = Device Identifier (DI) + Production Identifier (PI)
Device Identifier: A mandatory, fixed portion of the UDI that identifies the specific version or model of a
device and the labeler of that device. Thus, the two key components are:
• Specific version or model of device
• Labeler
Production Identifier: A conditional, variable portion of the UDI that identifies one or more of the
following, when included on the label of the device:
• Lot or batch
• Serial number
• Expiry date (use by date)
• Date of manufacture
C. Standardized Date Format
Hello, I'm from HCL's Engineering and R&D Services. We enable technology led organizations to go to market with innovative products and solutions. We partner with our customers in building world class products and creating associated solution delivery ecosystems to help bring market leadership. We develop engineering products, solutions and platforms across Aerospace and Defense, Automotive, Consumer Electronics, Software, Online, Industrial Manufacturing, Medical Devices, Networking & Telecom, Office Automation, Semiconductor and Servers & Storage for our customers. For more details contact: [email protected] Follow us on Twitter: http://twitter.com/hclers & LinkedIn: http://lnkd.in/bt8hDXM View our blog-site: http://www.hcltech.com/blogs/engineering-and-rd-services Visit our website: http://www.hcltech.com/engineering-rd-services
Standardized formats for dates on medical device labels consistent with international practices will
eliminate confusion from date formats that might be interpreted in more than one way. Dates must
therefore be presented in a specified format that is consistent with international standards and
international practice. The format is: YYYY-MM-DD.
UDI Compliance Dates for Medical Devices
UDI Product Class Label/GUDID/Date
Format
Permanent UDI
Class III
Devices licensed under the
PHS Act
September 24, 2014 Class III Life Sustaining / Life
Supporting (LS/LS) devices must bear a
permanent UDI by September 24, 2015
All other Class III devices must bear a
permanent UDI by September 24, 2016
I/LS/LS (class II, class I &
unclassified)
September 24, 2015 September 24, 2015
Class II September 24, 2016 September 24, 2018
Class I or unclassified September 24, 2018 September 24, 2020
Hello, I'm from HCL's Engineering and R&D Services. We enable technology led organizations to go to market with innovative products and solutions. We partner with our customers in building world class products and creating associated solution delivery ecosystems to help bring market leadership. We develop engineering products, solutions and platforms across Aerospace and Defense, Automotive, Consumer Electronics, Software, Online, Industrial Manufacturing, Medical Devices, Networking & Telecom, Office Automation, Semiconductor and Servers & Storage for our customers. For more details contact: [email protected] Follow us on Twitter: http://twitter.com/hclers & LinkedIn: http://lnkd.in/bt8hDXM View our blog-site: http://www.hcltech.com/blogs/engineering-and-rd-services Visit our website: http://www.hcltech.com/engineering-rd-services
UDI Implementation – Process Approach Figure 3: Step-by-step implementation of UDI
Develop UDI product
assessment list
Prioritize products based on
medical device classification
Are Label
changes
major label
issues?
Provide UDI requirements
Initiate label changes for UDI
compliance
Initiate design changes on the
label
Provide product-specific Device
Identifier and Production Identifier
requirements
Design and develop label
changes
Approve UDI label changes
Update DHF and DMR
Implement UDI label
on devices
Submit device
information to GUDID
Identify UDI impacted products
YES
NO
Hello, I'm from HCL's Engineering and R&D Services. We enable technology led organizations to go to market with innovative products and solutions. We partner with our customers in building world class products and creating associated solution delivery ecosystems to help bring market leadership. We develop engineering products, solutions and platforms across Aerospace and Defense, Automotive, Consumer Electronics, Software, Online, Industrial Manufacturing, Medical Devices, Networking & Telecom, Office Automation, Semiconductor and Servers & Storage for our customers. For more details contact: [email protected] Follow us on Twitter: http://twitter.com/hclers & LinkedIn: http://lnkd.in/bt8hDXM View our blog-site: http://www.hcltech.com/blogs/engineering-and-rd-services Visit our website: http://www.hcltech.com/engineering-rd-services
UDI Compliance in Warehouse Operations Ensuring UDI compliance with warehouse operations is also important, as it increases customer
satisfaction, decreases financial risk, and satisfies regulatory compliance. With the requirements that
the UDI has placed on the organization, ensuring compliance with the factors at the warehouse is
significant:
Rework and re-label products:
• Warehouse’s FDA registration status to ensure it is listed as a re-packaging/re-labeling facility
• Specific processes and procedures for rework
• Maintain adequate inventory while rework is being done
• Ensure a clearly identifiable marker on the package to designate origin
• Establish a mechanism for identifying items that should/should not be re-labeled
Perform product dimensioning or information gathering:
• Requirement to dimension a product if no dimensions are found in the system, or to periodically re-
dimension inventory
• Verify information required for the GUDID from existing product labeling
• Ensure accuracy and consistency; consider using standardized forms or pictures to confirm the
information being sent to the manufacturer
Change barcode formats that affect scanners:
• Capital expenditures for new barcode scanners, image scanners, barcode printers and wireless
infrastructure
• Impact to warehouse workflows and processes, quality procedures, technical implementation, on-
going support, and operational headcount
• Synchronization of standards in the supply chain. e.g. GS1 format, HIBCC
• Impact due to change to a different barcode format, such as linear stacked or linear concatenated to
a 2D data matrix format
• New barcode scanners, printers and software have to be tested and validated
• Need of additional programming to existing scanners to parse, translate, and look up data from the
alternate format
Increase stock level:
• Ramp up production to ensure sufficient stores of inventory during the transition period
• Additional space in warehouses to manage inventory ramp up
Maintain multiple versions of the same product with different labels:
• Stock control challenges for warehouses due to labelling changes and impact on international
registrations
Hello, I'm from HCL's Engineering and R&D Services. We enable technology led organizations to go to market with innovative products and solutions. We partner with our customers in building world class products and creating associated solution delivery ecosystems to help bring market leadership. We develop engineering products, solutions and platforms across Aerospace and Defense, Automotive, Consumer Electronics, Software, Online, Industrial Manufacturing, Medical Devices, Networking & Telecom, Office Automation, Semiconductor and Servers & Storage for our customers. For more details contact: [email protected] Follow us on Twitter: http://twitter.com/hclers & LinkedIn: http://lnkd.in/bt8hDXM View our blog-site: http://www.hcltech.com/blogs/engineering-and-rd-services Visit our website: http://www.hcltech.com/engineering-rd-services
Impact on Distributors:
• Training for distributors – According to the FDA, distributors are required to know about UDI
implementation on medical devices
• Distributors should consider adding UDI as a product reference in their items master
• Compliance to the specific guidelines provided by FDA for the processing and relabeling of returns
GUDID Requirements The Global Unique Device Identification Database (GUDID) is a publicly searchable database
administered by the FDA that will serve as a reference catalogue for every device with an identifier.
Labelers must electronically submit information on each device to the GUDID.
Global Unique Device Identification Database (GUDID) Data = DI (not PI) + Device Attributes
The information to be submitted to the FDA is categorized into the GUDID elements below:
• Identification
• Regulation
• Packaging
• Characteristics
• Labeler
• Production
This includes,
• The device identifier
• The types of production identifiers
• The proprietary, trade or brand name
• The version or model number
• The size, if the device comes in more than one size
• The number of devices/packages
• Whether the device is sterile, non-sterile or requires sterilization
• If it contains latex
• The FDA 510(k) or PMA number or a statement that the device is exempt
• The FDA listing number (required, but not posted publically)
• The GMDN code (only if GMDN codes become freely available by the publication of the final rule)
Hello, I'm from HCL's Engineering and R&D Services. We enable technology led organizations to go to market with innovative products and solutions. We partner with our customers in building world class products and creating associated solution delivery ecosystems to help bring market leadership. We develop engineering products, solutions and platforms across Aerospace and Defense, Automotive, Consumer Electronics, Software, Online, Industrial Manufacturing, Medical Devices, Networking & Telecom, Office Automation, Semiconductor and Servers & Storage for our customers. For more details contact: [email protected] Follow us on Twitter: http://twitter.com/hclers & LinkedIn: http://lnkd.in/bt8hDXM View our blog-site: http://www.hcltech.com/blogs/engineering-and-rd-services Visit our website: http://www.hcltech.com/engineering-rd-services
GUDID Data Submission Methods Figure 4: The various data submission methods of GUDID
Medical Device
Manufactu
GUDID data collection for submission
(PLM, MDM, ERP/MES, RA,
labelling)
Manual Data Entry FDA GUDID Web Interface
Hosted Software
Outsourced Service
Internal Software
SPL
SPL
SPL
GUDID Data
Hello, I'm from HCL's Engineering and R&D Services. We enable technology led organizations to go to market with innovative products and solutions. We partner with our customers in building world class products and creating associated solution delivery ecosystems to help bring market leadership. We develop engineering products, solutions and platforms across Aerospace and Defense, Automotive, Consumer Electronics, Software, Online, Industrial Manufacturing, Medical Devices, Networking & Telecom, Office Automation, Semiconductor and Servers & Storage for our customers. For more details contact: [email protected] Follow us on Twitter: http://twitter.com/hclers & LinkedIn: http://lnkd.in/bt8hDXM View our blog-site: http://www.hcltech.com/blogs/engineering-and-rd-services Visit our website: http://www.hcltech.com/engineering-rd-services
HCL’s GUDID Data Submission Approach HCL has suggested the use of the Electronic Submissions Gateway (ESG) method, particularly as the
amount of data is large and it will help avoid data entry errors.
Software Details
Technology: .NET Framework
Language: C#
Tools: Microsoft Visual Studio 2010
Approach
• Data is validated
• XML files are generated based on SPL and HL7 standards
• XML files are validated against the schema given by the FDA
• Automation of uploading XML files into ESG
Benefits
• Avoids data entry errors
• Uploading effort is reduced by 70% with the automation framework
• Schema validation check reduces errors in the production environment
• Cost-effective
HCL’s GUDID Data Submission Approach
Figure 5: HCL’s data submission approach for GUDID
UDI Issuing Agencies An issuing agency is an FDA-accredited organization that operates a system for the assignment of UDIs
according to the final rule. The FDA has accredited the agencies listed below:
1. Firm Name: GS1
GUDID Data Collection for
(PLM, MDM, ERP/MES, RA,
Labelling)
GUDID Data Submission
GUDID Data
Medical Device Manufacturer
Hello, I'm from HCL's Engineering and R&D Services. We enable technology led organizations to go to market with innovative products and solutions. We partner with our customers in building world class products and creating associated solution delivery ecosystems to help bring market leadership. We develop engineering products, solutions and platforms across Aerospace and Defense, Automotive, Consumer Electronics, Software, Online, Industrial Manufacturing, Medical Devices, Networking & Telecom, Office Automation, Semiconductor and Servers & Storage for our customers. For more details contact: [email protected] Follow us on Twitter: http://twitter.com/hclers & LinkedIn: http://lnkd.in/bt8hDXM View our blog-site: http://www.hcltech.com/blogs/engineering-and-rd-services Visit our website: http://www.hcltech.com/engineering-rd-services
2. Firm Name: HIBCC
3. Firm Name: ICCBBA
General Exceptions There are a number of UDI exceptions that are typical for FDA device regulations such as custom devices,
investigational devices, class I GMP (Good Manufacturing Practice) exempt devices, veterinary devices,
export-only devices, devices used solely for research or teaching, combination products, shipping
container, individual single use devices, and devices held by the national stockpile.
Benefits of UDI Implementation
Figure 6: The advantages of UDI implementation in medical devices
Rapid identification of a device to obtain key attributes thataffect its safe and effective use
Reduces medical errors
Identifies problems with a particular device (recalls)
Allows rapid and accurate review and assessment of adverseevent reports
Standardizes the date format on all device labels
Enhances business processes – Improves supply chainprocesses, inventory management and enhance procurement
Improves device traceability, post-market surveillance, anddetection of counterfeit products
Simplifies the integration of device use information into datasystems (electronic patient records)
Allows more rapid and effective corrective actions
Hello, I'm from HCL's Engineering and R&D Services. We enable technology led organizations to go to market with innovative products and solutions. We partner with our customers in building world class products and creating associated solution delivery ecosystems to help bring market leadership. We develop engineering products, solutions and platforms across Aerospace and Defense, Automotive, Consumer Electronics, Software, Online, Industrial Manufacturing, Medical Devices, Networking & Telecom, Office Automation, Semiconductor and Servers & Storage for our customers. For more details contact: [email protected] Follow us on Twitter: http://twitter.com/hclers & LinkedIn: http://lnkd.in/bt8hDXM View our blog-site: http://www.hcltech.com/blogs/engineering-and-rd-services Visit our website: http://www.hcltech.com/engineering-rd-services
Conclusion
The implementation of UDI in medical devices improves patient safety and healthcare business
processes. This will fundamentally change and improve the way we all interact with medical devices.
When the UDI system is fully implemented, it can serve several important public health objectives.
HCL Technologies, as one of the medical device service providers in the world, supports the
implementation of the UDI system in the medical device manufacturing industry. HCL understands the
fundamental concepts and processes of the UDI system, and supports its global clients in implementing
it with great confidence.
References • http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/def
ault.htm
• http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/Gl
obalUDIDatabaseGUDID/default.htm
• https://www.federalregister.gov/articles/2013/09/24/2013-23059/unique-device-identification-
system
• www.gs1.org
Hello, I'm from HCL's Engineering and R&D Services. We enable technology led organizations to go to market with innovative products and solutions. We partner with our customers in building world class products and creating associated solution delivery ecosystems to help bring market leadership. We develop engineering products, solutions and platforms across Aerospace and Defense, Automotive, Consumer Electronics, Software, Online, Industrial Manufacturing, Medical Devices, Networking & Telecom, Office Automation, Semiconductor and Servers & Storage for our customers. For more details contact: [email protected] Follow us on Twitter: http://twitter.com/hclers & LinkedIn: http://lnkd.in/bt8hDXM View our blog-site: http://www.hcltech.com/blogs/engineering-and-rd-services Visit our website: http://www.hcltech.com/engineering-rd-services
Authors Info Ragasudha Veerabathiran
Ragasudha has a Bachelor’s Degree in Biomedical Engineering. She has over 4 years of experience in the
Medical Devices domain as a Quality and Regulatory Affairs Engineer. She was also involved in getting CE
and UL marking for medical devices. She is experienced in creating and maintaining DHF (Design History
Files), TCF (Technical Construction Files), Dossiers for EU Submissions (CE & UL Mark) and FDA (510k)
submissions.
Mathiyazhagan Muthusamy
Mathiyazhagan has a Master’s Degree in Applied Chemistry and Chemical Engineering. He has over 27
years’ experience, of which 18 years were spent in the Medical Devices domain as Quality Head, R&D,
Quality Management Representative for US FDA-QSR, ISO 13485, MDD (CE Mark) and Certified Lead
Auditor for Quality Management Systems. He is currently working in an engagement for a large Medical
Devices OEM across quality, design control, and manufacturing and sustaining services areas.
Hello, I'm from HCL's Engineering and R&D Services. We enable technology led organizations to go to market with innovative products and solutions. We partner with our customers in building world class products and creating associated solution delivery ecosystems to help bring market leadership. We develop engineering products, solutions and platforms across Aerospace and Defense, Automotive, Consumer Electronics, Software, Online, Industrial Manufacturing, Medical Devices, Networking & Telecom, Office Automation, Semiconductor and Servers & Storage for our customers. For more details contact: [email protected] Follow us on Twitter: http://twitter.com/hclers & LinkedIn: http://lnkd.in/bt8hDXM View our blog-site: http://www.hcltech.com/blogs/engineering-and-rd-services Visit our website: http://www.hcltech.com/engineering-rd-services