Question
Sabrina Dessources
Senior Manager Regulatory Affairs-CMC at Alexion Pharmaceuticals, Inc.
August 2015
Good morning everyone, I need some advice please! Hopefully someone can shed some light! The company manufactures IVD devices, and the QMS is currently in conformity with BS EN ISO 13485 (and all other applicable EN ISO Standards). Because we will al...
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...
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: ...
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
I’ll be honest: I can’t even imagine what it’s like to learn my implant is being recalled. But that’s what happened to a group member who prefers anonymity for legal reasons. She writes: “I was appalled to receive a letter that my two-year-old hip re...
