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- Risk classification rationale
- Declaration of Conformity
- Reference to similar and previous versions of the device (located in our device description)
- Manufacturing process flow & manufacturing site certifications
- Risk management file
- Summary of design changes
- State-of-the-art & clinical evaluation report
- Notified Body application for CE Marking
- ISO 13485 Certificate
- PMS Plan & PMCF Plan
- quality system documentation (only sampled during FDA inspections–not during as part of the 510k process)
- supplier agreements and supplier auditing may be conducted, depending upon the ISO 13485 certification of the suppliers
- training effectiveness and competency of employees
- suitability of the infrastructure and work environment for manufacturing your medical device
- Project management tools and templates
- Comparison of 510k and Technical File requirements
- References to US & European guidance documents
- Suggested timing for the overall combined regulatory plan
When was this webinar on how to combine 510k submissions with CE Marking technical files created?
This webinar was initially hosted live in 2015, and we re-recorded the webinar on April 4, 2022. The updated webinar now includes revisions to the 510k process to reflect the implementation of the FDA eSTAR template and changes to the CE Marking technical file review process resulting from Regulation (EU) 2017/745 coming into force in 2021.Who should watch this video?
- Regulatory Affairs
- Product Development / R&D
Combine 510k with CE Technical File
The webinar provides an overview of the 510(k) submission and CE Marking processes. We explain which parts of the submissions are similar where you can repurpose content from one submission for the other. We identify changes to the 510(k) process resulting from the implementation of FDA eSTAR templates. We identify changes to the CE Marking process resulting from the implementation of the MDR. Finally, we explain why these changes have shifted the entire medical device industry from a European market first strategy to a US market first strategy. Price: $64.50
About the Instructor
