Question
Rick Gerace
Business executive with accounting foundation and 20+ years’ experience in financial, operational & project management.
June 2015
source: https://www.linkedin.com/groups/78665/78665-6011678424828043267
What is considered best practice for assessing effectiveness of change control actions within the QMS? I am wondering if a CC file remains open during this period or whether it is closed at execution and then tracked separately, e.g. as a CAPA. Alter...
Can someone please clarify?If a product is classed as exempt ie (Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 872.9. If the device i...
Long-time readers won't be surprised that 13485-expert Robert Packard's workshop at the 10x Conference was standing room only. Or that he offered to teach his class for free. Register at http://medgroup.biz/510k-tips for Rob's free workshop on how to...
I'm now dealing with 510k, but can not understand from FDA website...From the "Deciding When to Submit a 510(k) for a Change to an Existing Device" in FDA website, it states "documentation" as document your analysis and file it for future reference. ...
Hello, I am going for a CE Mark for my class IIa device. In order to understand the process better I came across STED scheme. I was wondering if someone has taken their device through STED and what was their experience?source: https://www.linkedin.co...
We are not going for FDA compliance. We do however have a lot of ASTM, FCC and such certifications, not UL though.A doctor is asking for certification that our product won't hurt the baby (rashes, electric burns, etc). How do we certify this?source: ...
A question from group member Mike Murphy QA Consultant, Combination Product Launch at The Medicines Company: Can anyone share experience of change EC-REP address (within the same country or otherwise)? How much time do NCA's allow to remediate IFU's ...
UDI regulations kick in for Class I and II devices in 2015. So let's start the year with a free webinar for ways to make your UDI submissions easier. http://medgroup.biz/UDI-in-2015 Reed Tech is my go-to on this subject. They'll cover: • Requirements...
Chuck M Calvert, MBA
Repeat Winner • Medical Device • IoT• SaaS • Blockchain • Techie who can sell! .. 4 IPOs, SME SALES- Presidents Club!
January 2015
I'm searching for a list of ISO 13485 Certified Medical Device Manufacturing facilities.Do you have a manufacturer you would recommend?source: https://www.linkedin.com/groups/4372308/4372308-5958098871316926465
