Why? This is why:
If I’m going to save you from reading this (what’s the word?), um, stuff, I’m going to have to read and understand:
- 80 pages of the Medical Device Directive
- 175 pages of the Medical Device Regulations
- 25 pages of the ISO 13485:2016 Standard
- 225 pages of the ISO 13485:2016 Practical Guide for Implementation
- 400 pages (approximately) among 20 new FDA Guidance Documents
- 1,000 pages of international standards among 400+ pending updates
- 205 pages about the MDSAP audit program, along with its companion guide
Not to mention all the coming documents from the EU(!), including:
- Delegating and Implementing Acts
- Common Specifications (whatever that means)
- Common Understanding (whatever that means)
- MEDDEV Guidance for 2018
You can see where I’m going with this.
You know, I’m going crazy and “so you don’t have to” is the good part.
Schedule some time, let’s talk about it.
I can’t “make it all go away” but I can make it a heck of a lot easier for you to stay compliant!
+ Michelle +