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Slide 1 of 11 April 2014 Rob Packard, President Regulatory Pathways 101: Your 1 st Product Launch in Canada,

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Presentation on theme: "Slide 1 of 11 April 2014 Rob Packard, President Regulatory Pathways 101: Your 1 st Product Launch in Canada,"— Presentation transcript:

1 Slide 1 of 11 April 2014 Rob Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com Regulatory Pathways 101: Your 1 st 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 Need Help Getting Started?

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