proven process medical devices, design, development, testing, and manufacture
TRANSCRIPT
WHO WE ARE
OUR EXPERIENCE
• FDA Class II and III therapeutic and
diagnostic device product
development and manufacturing
• A mature, well developed ISO 13485
quality system
• Efficient and effective, Best-in-Class
for rapid Time-to-Market
OUR FOCUS
• Exclusively focused on medical
devices since 1994
• Medical capital equipment, patient
monitoring, implantable and
disposable devices, in-vitro
diagnostics
• Success with devices in accordance
with FDA, EU MDD, AIMDD and
IVDD
WE ARE TRUSTED
• Customers Include Industry Leaders and
Emerging Companies
• High Customer Return Rate
• ISO 13485:2003 Certified
• FDA Registered & Successfully Audited
STAFF RESOURCES
• Engineering
Development
Quality
Manufacturing
• Quality Assurance
• Regulatory Support
• Manufacturing
MAJOR MARKETS SERVED
• Medical Robotics
• Drug Delivery Devices
• Cardiac Assist
• Cardiac Rhythm Management
• Neuromodulation / Pain Management
• Patient Monitoring
• In-Vitro Diagnostic Devices
• Catheters
• Vascular Access Devices
• Minimally Invasive Surgical Devices
• Instrument Reprocessing Equipment
• Combination Devices
WHAT WE DO
DESIGN &
DEVELOPMENT
VERIFICATION
& VALIDATION
CONTRACT
MANUFACTURING • Pilot & Full Scale
Manufacturing
• FDA Registered
• ISO 13485 Certified
Concept to Customer ℠
• Product Verification &
Process Validation
• Domestic &
International
Compliance
• Product Definition
• Concept Design
• Prototype
Development
• Design for
Manufacturing
DESIGN & DEVELOPMENT
MECHANICAL ENGINEERING
• Mechanical / Electro-Mechanical
Mechanisms
• Molded and Extruded Components &
Devices
• Macro and Micro Fluidics Components
• Pneumatics
• Biocompatible Materials Selection
• Finite Element Analysis
• Computational Fluid Dynamics Analysis
• Sterile and Non-Sterile Packaging
• Rapid Prototyping
ELECTRICAL & ELECTRONIC ENGINEERING
• IEC 60601 Medical Grade Electronics
• Physiological Data Acquisition
• Embedded Microprocessor Devices
• Application Specific Integrated Circuits
(ASIC, FPGA, Gate Array, etc.)
• Wireless Communication Including
Inductive, MICS, Bluetooth, and 802.11
• Digital Signal Processing (DSP) Solutions
• Printed Circuit Board Design
• Battery Operated and Low Power Devices
• Motor and Motion Control
• Analog and Digital Design and Simulation
SOFTWARE DEVELOPMENT
• Medical Grade Software Development
using ANSI / IEC 62304 Lifecycle
• Compliant with FDA Guidance’s and
International Standards
• Major Languages Include C, C++, C#,
Visual Basic, and Assembly Languages
• Software for Windows, Linux, QNX and
Other Major RTOS
• Embedded Microprocessor
Software / Firmware
• Digital Signal Processor Software
• Automated Test Equipment Software
• Independent Software V&V
PRODUCT DESIGN AND PROCESS
VERIFICATION & VALIDATION
• Verification & Validation Planning
• Risk Management per ISO 14971
DESIGN VERIFICATION
• Functional and Performance Verification
• Environmental Testing
• Biocompatibility Verification per ISO 10993
• Sterility Verification per ISO 11607
• Electrical Safety and EMC per IEC 60601
• Packaging Transit Verification per ASTM
or ISTA standards
• Software Validation
• Equipment IQ / OQ / PQ
• Process FMEA
• Validation of Special Processes
• Process Capability Analysis
FABRICATION & ASSEMBLY
PROCESS VALIDATION
CONTRACT MANUFACTURING
• FDA Registered and ISO 13485 Certified
Manufacturing and Capability
• Mechanical and Electronics Assemblies
• Disposables
• Sterile and Non-Sterile Packaging
• Medium Volume / High Mix Production
Assembly
• Incoming Inspection and Warehousing
Controls
• Enterprise Resource Planning (ERP)
Tracking
• Supply Chain Management Including
Approved Supplier Program
OUR PROVEN PROCESS
PROJECT MANAGEMENT PROCESS
• Project Management Starts at the
Proposal Phase
• Free Initial Consultation to Determine
Customer Needs
• Detailed Project Planning Model
Developed for Proposal and Initial
Project Tracking
• Collaborative Review and Fine Tuning of
the Model with Customer to Properly
Align Project Plan with Customer’s
Needs
• PPMD Can Manage Multiple Groups
Globally
PROJECT MANAGEMENT PROCESS
• Dedicated Project Teams Assigned
to Customers
• Weekly Status Tracking Meetings, Using
Web Conferencing for Remote
Participants, for Each Project
• Utilize Project Management Controlling
Metrics Including Milestone and
Cost Tracking
• On Site Conference Facilities Available
to Customers
MEDICAL DEVICE PORTFOLIO
• Concept to Customer Development and
Manufacturing
• Precise Pneumatic Control
• High Reliability
CRITICAL LIFE SUPPORT SYSTEM
• Paradigm Shifting Technology Platform
• Precise Motion Control
• Ergonomic User Interface
• Complex Systems Integration
REMOTE & ROBOTIC DEVICES
• Precise Fluid Control
• Power Injection
• Ergonomic User Interface
• Complex Systems Integration
• IEC 60601-24 and FDA Infusion Pump
Guidance Compliance
FLUID INJECTION AND MEDICATION
DELIVERY PRODUCTS
• Concept to Customer Development and
Manufacturing
• Complex Electro-Mechanical Fluid Handling
• Implantable Microelectronics
• Novel Implantable Materials
• Integrated Medical Grade Software
PROGRAMMABLE & CONSTANT
FLOW IMPLANTABLE PUMPS
• Intuitive User Interface
• Bi-Directional Wireless Communication
• Patient Data Retention
HAND HELD MEDICAL DEVICES
• Continuous Physiological Monitoring (Blood
Glucose)
• Wireless Communication
• Ultra Low Power
• Medical Grade Software
HAND HELD MEDICAL DEVICES
• Product Development and Validation
• Low Cost, High Volume Disposable Systems
• Design for Automated Assembly and Test
DISPOSABLE ELECTRONIC &
ELECTRO-MECHANICAL DEVICES
• Product Development and Validation
• Low Cost, High Volume Disposable Systems
• Design for Automated Assembly and Test
DISPOSABLE ELECTRONIC &
ELECTRO-MECHANICAL DEVICES
• Product Development and Validation
• Low Cost, High Volume Disposable Systems
• Design for Automated Assembly and Test
DISPOSABLE ELECTRONIC &
ELECTRO-MECHANICAL DEVICES
• Catheter Material Selection
• Metal and Plastic Port Bodies
• Proprietary Interconnects
• Pressure & Flow Characteristics Optimized
with CFD
• Sterile Package Design
CATHETERS, VASCULAR ACCESS
PORTS, STERILE KITS
• Concept to Customer Development and
Manufacturing
• Complex Electro-Mechanical Fluid Handling
• Closed Loop Control Using Fluid Level,
Pressure, Temperature and Ozone Feedback
• Medical Grade Software
PARADIGM SHIFTING CLEANING
& STERILIZATION EQUIPMENT
CLASS II & III MEDICAL DEVICE
CONTRACT MANUFACTURING
