iso 13485:2016 medical devices training handbook€¦ · written, electronic or oral communication...

Department TRG Project No. 180102 Document No. PHA001 Doc Rev. 01

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ISO 13485:2016 Medical Devices Training Handbook

Presented By Maria Mylonas



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How to use this handbook

The handbook is organized to focus on particular skills and revisions. These lessons allow you to learn and practice the skills used throughout the course. The following icons are used in this handbook.

Activity Revision exercise or written task

Important Important points to remember for the assessment

Quick Link or Tip A shortcut, tip, or favourite link

Discussion Group discussion activity

This intellectual property remains the property of PharmOut Pty Ltd. It is intended for training purposes and its format and contents are copy written by ©PharmOut 2018. For further information go to www.pharmout.net



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Table of Contents

How to use this handbook ................................................................................................. 2 1. Terms and definitions ............................................................................................... 4 2. Activity 1: Select the Medical Device ........................................................................ 6 3. Activity 2: ISO 13485:2016 - Section 4’s Annex A review ........................................ 8 4. Activity 3: ISO 13485:2016 - Section 5 & 6’s Annex A review .................................. 9 5. Activity 4: Customer Requirements ........................................................................ 10 6. Activity 5: Process validation .................................................................................. 12 7. Activity 6: ISO 13485:2016 - Section 7’s Annex A review ...................................... 13 8. Activity 7: Corrective and Preventive Actions (CAPA) ............................................. 14 9. Activity 8: ISO 13485:2016 - Section 8’s Annex A review ...................................... 15 10. Activity 9: ISO 13485:2016 considerations for transition ....................................... 16



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1. Terms and definitions

Source ISO 13485:2016

Term Definition

Advisory notice

Notice issued by the organization, subsequent to delivery of the medical device, to provide supplementary information or to advise on action to be taken in the: — use of a medical device, — modification of a medical device, — return of the medical device to the organization that supplied it, or — destruction of a medical device

Authorized representative

Natural or legal person established within a country or jurisdiction who has received a written mandate from the manufacturer to act on his behalf for specified tasks with regard to the latter’s obligations under that country or jurisdiction’s legislation [source: ghtf/sg1/n055:2009, 5.2]

Clinical evaluation

Assessment and analysis of clinical data pertaining to a medical device to verify the clinical safety and performance of the device when used as intended by the manufacturer [source: ghtf/sg5/n4:2010, clause 4]

Complaint

Written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, usability, safety or performance of a medical device that has been released from the organization’s control or related to a service that affects the performance of such medical devices Note 1 to entry: This definition of “complaint” differs from the definition given in ISO 9000:2015.

Distributor

Natural or legal person in the supply chain who, on his own behalf, furthers the availability of a medical device to the end user [source: ghtf/sg1/n055:2009, 5.3]

Implantable medical device

Medical device which can only be removed by medical or surgical intervention and which is intended to: — be totally or partially introduced into the human body or a natural orifice, or — replace an epithelial surface or the surface of the eye, and — remain after the procedure for at least 30 days

Importer Natural or legal person in the supply chain who is the first in a supply chain to make a medical device, manufactured in another country or jurisdiction, available in the country or jurisdiction where it is to be marketed [source: ghtf/sg1/n055:2009, 5.4]

Labelling

Label, instructions for use, and any other information that is related to identification, technical description, intended purpose and proper use of the medical device, but excluding shipping documents [source: ghtf/sg1/n70:2011, clause 4]

Life-cycle

All phases in the life of a medical device, from the initial conception to final decommissioning and disposal [source: ISO 14971:2007, 2.7]

Manufacturer

Natural or legal person with responsibility for design and/or manufacture of a medical device with the intention of making the medical device available for use, under his name; whether or not such a medical device is designed and/or manufactured by that person himself or on his behalf by another person(s) [source: ghtf/sg1/n055:2009, 5.1]



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Medical device

Instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of: — diagnosis, prevention, monitoring, treatment or alleviation of disease; — diagnosis, monitoring, treatment, alleviation of or compensation for an injury; — investigation, replacement, modification, or support of the anatomy or of a physiological process; — supporting or sustaining life; — control of conception; — disinfection of medical devices; — providing information by means of in vitro examination of specimens derived from the human body; and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means [source: ghtf/sg1/n071:2012, 5.1]

Medical device family

Group of medical devices manufactured by or for the same organization and having the same basic design and performance characteristics related to safety, intended use and function

Performance evaluation

Assessment and analysis of data to establish or verify the ability of an in vitro diagnostic medical device to achieve its intended use

Post-market surveillance

Systematic process to collect and analyse experience gained from medical devices that have been placed on the market

Product Result of a process [source: ISO 9000:20052), 3.4.2, modified]

Purchased product Product provided by a party outside the organization’s quality management system

Risk Combination of the probability of occurrence of harm and the severity of that harm [source: ISO 14971:2007, 2.16]

Risk management

Systematic application of management policies, procedures and practices to the tasks of analysing, evaluating, controlling and monitoring risk [source: ISO 14971:2007, 2.22]

Sterile barrier system

Minimum package that prevents ingress of microorganisms and allows aseptic presentation of the product at the point of use [source: ISO 11607‑1:2006, 3.22]

Sterile medical device Medical device intended to meet the requirements for sterility



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2. Activity 1: Select the Medical Device

Based on Module 1 – Introduction Read the following background information:

What is a Medical Device? According to ARGMD (V1.1 May 2011) a medical device is.... a. any instrument, apparatus, appliance, material or other article (whether used alone or in combination, and including the software necessary for its proper application) intended, by the person under whose name it is or is to be supplied, to be used for human beings for the purpose of one or more of the following:

i. diagnosis, prevention, monitoring, treatment or alleviation of disease;

ii. diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability;

iii. investigation, replacement or modification of the anatomy or of a physiological process;

iv. control of conception; v. and that does not achieve its principal intended action

in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its function by such means; or

aa. any instrument, apparatus, appliance, material or other article specified under subsection (2A); or ab. any instrument, apparatus, appliance, material or other article that is included in a class of instruments, apparatus, appliances, materials or other articles specified under subsection (2B); or b. an accessory to such an instrument, apparatus, appliance, material or other article covered by paragraph (a), (aa) or (ab).



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1. Select one of the devices below and assess if it is a medical device or not. 2. Refer to any part of the definition provided above.

• Work in groups (or by table depending on the number of participants). • Discuss for 10-15 minutes, nominate one person to present to the group

. Use the space below to record your answers.

Select the Medical Device and why?

Device Medical Device? Y / N

Definition section

1. Contact Lens

2. Crutch

3. Pacemaker

4. Pacemaker battery

5. Stethoscope

6. Stent

7. Examination bed

8. X-ray machine

9. Barium dye

10. Dentist’s examination mirror

11. Replacement hip joint

12. Blood pressure monitors

13. Arm sling

14. Custom-made orthotics



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3. Activity 2: ISO 13485:2016 - Section 4’s Annex A review

Notes:



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4. Activity 3: ISO 13485:2016 - Section 5 & 6’s Annex A review

Notes:



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5. Activity 4: Customer Requirements

Based on Module 4 – Product Realisation 1. Select a device from the list in Activity 1 “Select the Medical Device”. 2. Identify requirements that may be specified by the customer. 3. Identify requirements that may not be specified by the customer. • Work in groups (or by table depending on the number of participants). • Discuss for 10-15 minutes, nominate one person to present to the group

Use the space below to write down what aspects that you would concentrate on:

1. Medical Device:

2. Requirements specified by the customer:



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3. Requirements NOT specified by the customer:



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6. Activity 5: Process validation Your company manufactures Intravenous (IV) solutions bags. During the QA release process it was noticed that some of the bags had leaked. In groups, review the Diagram 1 complete Section A, B and C.

Diagram 1: Process map for manufacturing an IV bag (simplified)

Blow fill seal Surface treat Seal and cut Label Finished product

Section A: Identify the process step and CQA most likely the source of the faulty bag.

Process Step CQA

Section B: For the identified CQA list as many CPPs

Section C: Select one CPP identified and decide on an acceptance criteria for testing in the PV.

Section D: Where in the product lifecycle should these requirements be defined as part of a control strategy?



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Notes:



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8. Activity 7: Corrective and Preventive Actions (CAPA) Review the following scenario and answer the questions below.

Scenario: An Intravenous (IV) solutions bag manufacturer has a batch of released product returned with visible particulates in the bag. As a part of the risk assessment team you are tasked by the QA manager to determine the root cause of the failure and determine the appropriate Corrective and Preventive actions (CAPAs) to implement.

1. Complete the fish-bone diagram below to determine the root cause of the quality failure.

Cause Effect (describe the problem statement below)

Visual particulates observed in bags from released Batch ABC of product ‘IV bags’

2. List two Corrective Actions that should be implemented to correct the problem.

3. List two Preventive Actions that should be implemented to avoid the failure in the future.

People

Method

Measurement

Machine

Environment

Materials



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Notes:



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10. Activity 9: ISO 13485:2016 considerations for transition

In groups brainstorm as many ISO 13485:2016 transition considerations you can think of.

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iso 13485:2016 medical devices training handbook€¦ · written, electronic or oral communication...

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