Regulatory + Quality Assurance | Michelle Lott | lean RAQA

Industries

Medical Devices

Michelle's Regulatory Pathway Assessment helped me get investment proposals, reliable cost estimates, and the confidence I was "doing everything right."

  • Bill Lear
    President
    JULVIA

Regulation ain’t gettin’ any easier

Did you know FDA will have introduced TWENTY new guidances between September 2017 and December 2018?

Add in the transition to ISO 13485:2016.

And the new European Union Medical Devices Regulation (EU MDR).

Your medical device regulatory strategy should be similar to your tax strategy: You’re going to pay the taxes. But did you make the best choices to optimize your savings?

And you could absolutely do it on your own. But at what cost? Life? Liberty? The pursuit of happiness?

Nah. Work alongside someone who actually ENJOYS this stuff. Maybe even offload most of it to her.

How many can you confidently answer?

There’s no harm in not having all the answers. I didn’t. Then I researched the questions thoroughly and, after talking directly with FDA and other regulatory bodies, I got the answers.

Let me give you the answer key.

  1. On average, how many annual FDA regulatory changes should impact my business?
  2. I have a 510(k) clearance. What’s next in the commercialization process?
  3. Can I use my 510(k) clearance for entry in any country outside the US?
  4. What’s the difference between a 510(k) and a technical file?
  5. Does my contract manufacturer need to be FDA registered or ISO 13485 certified?
  6. Do I need a quality management system if my contract manufacturer is FDA registered and ISO 13485 certified?
  7. What types of ISO 13485 certifications are there? Will my selection impact which markets I can enter?
  8. What are the differences among class I, II, III, and unclassified devices?
  9. How do I know which device classification I am?
  10. How many FDA submission types are there? Which one is best for me?

So how’d you do?

Rank your performance:

🌟 10: You’re a superstar. What are you doing here? You’ve totally got this.
💪 9: Impressive! How I can complement what you’re already doing?
😬 8 or fewer: To be safe, put time on my calendar. “Too proud to ask Michelle” is no reason for a 483 or warning letter. Plus I like meeting new people!

Call me. It’s free. I only ask you pick an open half hour on my calendar.

Who knows? Maybe I can lighten your workload!

+ Michelle +