Regulatory + Quality Assurance | Michelle Lott | lean RAQA

Medical Devices

Regulation ain’t gettin’ any easier

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 a team that actually ENJOYS this stuff.

Maybe even offload most of it!

Check Out All These Flavors:

21 CFR 820.265(f)

Return to inventory – procedures

21 CFR 820.47(a)

Donor eligibility procedures

21 CFR 820.47(a)

Procedures for all steps

21 CFR 820.320(a)

Procedures re complaints

21 CFR 820.265(e)

Procedures and release criteria

21 CFR 820.75(e)

Abbreviated procedure

21 CFR 820.230(a)

Process validation procedures

21 CFR 820.190(d)(1)

Procedures for cleaning, sanitation

21 CFR 820.200(c)

Calibration procedures and schedules (general)

21 CFR 820.230(a)

Validation & approval – established procedures

Shall I Continue?

No, you get the idea. I hate to see bad things happen to companies doing good, important work. In my storied (indulge me) career, I’ve seen one too many “If only so-and-so followed the procedure, we could have avoided this” messes that cratered otherwise-promising technologies.

Call me so you can avoid the same fate. Please?

call me

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!

Help Has Arrived!

Pick an open half hour on my calendar. Maybe I can lighten your workload and I would LOVE to help!

let’s connect!