QA/RA Expert Robert Packard explains regulatory pathways to take in your first product launch for Medical Devices.

1. Slide 1 of 11
April 2014
Rob Packard, President
www.MedicalDeviceAcademy.com
rob@13485cert.com
Regulatory Pathways 101:
Your 1st Product Launch in
Canada, Europe and the USA

2. Slide 2 of 11
April 2014
Rob Packard, President
www.MedicalDeviceAcademy.com
rob@13485cert.com
What’s Your Goal?
• ISO 13485 Certification
• Canadian Medical Device Licensing
• CE Marking for Europe
• FDA 510(k) Clearance
• Sales

3. Slide 3 of 11
April 2014
Rob Packard, President
www.MedicalDeviceAcademy.com
rob@13485cert.com
7-Step Process
1. Regulatory Pathway
2. Strategic Decision
3. Gap Analysis
4. Quality Planning
5. Design Planning
6. Pre-Certification Activities
7. Certification Audits

4. Slide 4 of 11
April 2014
Rob Packard, President
www.MedicalDeviceAcademy.com
rob@13485cert.com
Step 1: Regulatory Pathway
• Device Classification Rationale
• Identification of Applicable Harmonized
Standards
• Regulatory Pathway for Each Market
• Recommendation for Sequence of
Submissions

5. Slide 5 of 11
April 2014
Rob Packard, President
www.MedicalDeviceAcademy.com
rob@13485cert.com
Step 2: Strategic Decision
• Which market first?
• Why?

6. Slide 6 of 11
April 2014
Rob Packard, President
www.MedicalDeviceAcademy.com
rob@13485cert.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

7. Slide 7 of 11
April 2014
Rob Packard, President
www.MedicalDeviceAcademy.com
rob@13485cert.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

8. Slide 8 of 11
April 2014
Rob Packard, President
www.MedicalDeviceAcademy.com
rob@13485cert.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

9. Slide 9 of 11
April 2014
Rob Packard, President
www.MedicalDeviceAcademy.com
rob@13485cert.com
Step 6: Pre-Certification Activities
• Internal Audits
• Supplier Audits
• CAPAs & SCARs
• Management Review

10. Slide 10 of 11
April 2014
Rob Packard, President
www.MedicalDeviceAcademy.com
rob@13485cert.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

11. Slide 11 of 11
April 2014
Rob Packard, President
www.MedicalDeviceAcademy.com
rob@13485cert.com
Schedule a Call
Glenn@MedicalDeviceAcademy.com
+1.561.308.3093
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