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QA/RA Expert Robert Packard explains regulatory pathways to take in your first product launch for Medical Devices.
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Slide 1 of 11
April 2014
Rob Packard, Presidentwww.MedicalDeviceAcademy.com
Regulatory Pathways 101:
Your 1st Product Launch inCanada, Europe and the USA
Slide 2 of 11
April 2014
Rob Packard, Presidentwww.MedicalDeviceAcademy.com
What’s Your Goal?• ISO 13485 Certification• Canadian Medical Device Licensing• CE Marking for Europe• FDA 510(k) Clearance
• Sales
Slide 3 of 11
April 2014
Rob Packard, Presidentwww.MedicalDeviceAcademy.com
7-Step Process1. Regulatory Pathway2. Strategic Decision3. Gap Analysis4. Quality Planning5. Design Planning6. Pre-Certification Activities7. Certification Audits
Slide 4 of 11
April 2014
Rob Packard, Presidentwww.MedicalDeviceAcademy.com
Step 1: Regulatory Pathway
• Device Classification Rationale• Identification of Applicable Harmonized
Standards• Regulatory Pathway for Each Market• Recommendation for Sequence of
Submissions
Slide 5 of 11
April 2014
Rob Packard, Presidentwww.MedicalDeviceAcademy.com
Step 2: Strategic Decision
• Which market first?
• Why?
Slide 6 of 11
April 2014
Rob Packard, Presidentwww.MedicalDeviceAcademy.com
Step 2: Gap Analysis• Requirements Table– 21 CFR 820– ISO 13485– Canadian Medical Device License Table of Contents– Technical File Index– 510(k) Table of Contents
• Color Coding of Gaps– Red– Yellow– Green
Slide 7 of 11
April 2014
Rob Packard, Presidentwww.MedicalDeviceAcademy.com
Step 4: Quality Planning• Applications• Task List• Assignment of Responsibilities• Target Completion Dates• Color Coding of Progress– Red– Yellow– Green
• Use the Management Review Process
Slide 8 of 11
April 2014
Rob Packard, Presidentwww.MedicalDeviceAcademy.com
Step 5: Design Planning• Recommended Design Reviews– Design Plan– Design Inputs– Design Outputs– Design Verification Protocols– Design Validation Protocols– Final Design Review
• Integration of Risk Management
Slide 9 of 11
April 2014
Rob Packard, Presidentwww.MedicalDeviceAcademy.com
Step 6: Pre-Certification Activities
• Internal Audits• Supplier Audits• CAPAs & SCARs• Management Review
Slide 10 of 11
April 2014
Rob Packard, Presidentwww.MedicalDeviceAcademy.com
Step 7: Certification Audits• Stage 1 ISO 13485 Certification Audit• Stage 2 ISO 13485 Certification Audit• Microbiology Audit• CE Marking Technical Audit• CE Marking Submission Review
Slide 11 of 11
April 2014
Rob Packard, Presidentwww.MedicalDeviceAcademy.com
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