Medical Device Quality Assurance and Compliance FAQs
- What does medical device compliance look like for my device?
- What does compliance look like for my software as a medical device (SAMD)?
- How many annual FDA guidance document changes might impact my business?
- I have an FDA 510(k) clearance. What’s next in the commercialization process?
- What kind of medical devices are 510(k) exempt? Am I 510(k) exempt?
- Can I use my 510(k) FDA clearance for entry into any country outside of the United States?
- How do I ensure I have all of the correct technical documentation in place to successfully bring my medical device to market?
- What is the correct technical documentation for my medical device compliance and regulatory strategy?
- What’s the difference between a 510(k) and a technical file?
- What is the difference between the FDA and a notified body?
- Does my contract manufacturer need to be FDA registered or ISO 13485 certified?
- Do I need a quality management system if my contract manufacturer is FDA-registered and ISO 13485-certified?
- Am I within 21 CFR 820 compliance?
- Does 21 CFR part 820 even apply to my medical device?
- What types of ISO 13485 certifications are there? Will my selection impact which markets I can enter?
- What are the differences among the FDA classifications? How do I determine if I have a class 1 medical device, class 2 medical device, class 3 medical device, or an unclassified medical device?
- How do I know which device FDA classification I have?
- How many FDA submission types are there? Which one is best for my device?
- What is the difference between intended use and indications for use?
- How do I choose the best FDA product code for my product?
EU MDR Specific Medical Device FAQs
- Do I have to deal with EU MDR?
- My software has been reclassified. What does that mean, and where do I start?
- My technology is long-standing, and my materials are well-established. Do I need a clinical evaluation report (CER)?
- I have ISO 13485 certification! Is that enough to sell my product?
- My product has been in the market for twenty years! Why do I need biocompatibility testing for submission now?
- How do I get a notified body?
- What are the quality system transitional requirements for EU MDR?
- Can I assemble my technical documentation and self-certify?
- Might they extend the EU MDR transition period again?
- How long does it take for a technical documentation review? My MDD certificate is expiring…
- Do I care about any of this? If I don’t have the passion for it, who does?
I Think I Need Help with Regulatory Affairs and Quality Assurance
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