I love a scavenger hunt as much as the next person. However, when it comes to medical device documents and records, your system and approach should not be the makings of a scavenger hunt. Whether you have been through this before or if this is the first time, I want you to take a few moments to consider the importance of the documentation your medical device company. Sure, you have to consider the regulations—FDA, ISO, and so on. But please, do not think about documentation as one of those things you have to do because the regulations say so. Okay, yes, the documents and records you generate during medical device product development, quality systems, and production activities is vitally important to demonstrate regulatory compliance. However, there is a much bigger purpose for all of this documentation. It’s your medical device company. The documents and records you generate as part of bringing a new medical device to market are necessary for your team. The Design Controls and Risk Management records are generated by teams of really smart people to demonstrate the medical devices you are developing are safe and effective. The documents and records you generate to support your quality system are necessary for the infrastructure of your medical device company. This documentation establishes sound, repeatable processes for you to measure and analyze in order to ensure maximum efficiency. For these reasons, the way you manage documents and records within your company should be intentional. It should not result in a scavenger hunt. Read the full article at: http://blog.greenlight.guru/how-to-avoid-medtech-document-records-scavenger-hunt

1. How to Avoid a Document &
Record Scavenger Hunt
BIOMEDevice Boston
May 7, 2015

3. Imagine the following scenarios
• Your company is in the process of bringing a new medical
device to market
• Your company has an ever evolving QMS
• Your company will be inspected by FDA and/or audited for ISO

4. How are you managing these scenarios?
• Battleship eQMS / eDMS?
• General purpose tools?
• Low powered legacy solution?
• Paper?

5. Do you . . .
• Bury your Design History Files once the medical device received
regulatory clearance and is launched?
• Archive the Risk Management File after the product is launched?
• Ensure all aspects of your QMS are in sync?

7. The home of your
documents & records

8. DHFs in binders?
Find a test report in this pile.

9. Paper . . .

10. How does
paper work
for global
teams?

11. “E”
systems
convert
paper to
digital

12. Signed documents
need to be scanned

13. Most “E”
systems
are no
better
than
paper

14. “E” systems – still a
scavenger hunt

16. Documents
are buried

17. Paper to “E”
– frustrating

19. A new frontier

20. FAST!

22. TARGETED

26. You need
• Single Source of Truth
• Reduce time during product development
• Onboard resources FAST
• Designed for Medical Device companies
• Always audit ready
• Resources more productive

28. Jon Speer
jon.speer@greenlight.guru
(765) 346-3987