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Navigating Regulatory Pathways: Launching Your First Product

Understand the ISO 13485 certification process, Canadian medical device licensing, CE marking for Europe, and FDA 510(k) clearance. Learn the 7-step process for strategic decision-making, gap analysis, quality planning, design planning, pre-certification activities, and certification audits. Expert guidance on device classification, harmonized standards, market sequences, requirements, internal audits, design reviews, risk management, and certification audits. Contact Glenn@MedicalDeviceAcademy.com for assistance.

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Navigating Regulatory Pathways: Launching Your First Product

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  1. Regulatory Pathways 101: Your 1st Product Launch in Canada, Europe and the USA

  2. What’s Your Goal? ISO 13485 Certification Canadian Medical Device Licensing CE Marking for Europe FDA 510(k) Clearance Sales

  3. 7-Step Process Regulatory Pathway Strategic Decision Gap Analysis Quality Planning Design Planning Pre-Certification Activities Certification Audits

  4. Step 1: Regulatory Pathway Device Classification Rationale Identification of Applicable Harmonized Standards Regulatory Pathway for Each Market Recommendation for Sequence of Submissions

  5. Step 2: Strategic Decision Which market first? Why?

  6. 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. 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. 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. Step 6: Pre-Certification Activities Internal Audits Supplier Audits CAPAs & SCARs Management Review

  10. 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. Schedule a Call Need Help Getting Started? Glenn@MedicalDeviceAcademy.com +1.561.308.3093

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