QA Team Leader at Blatchford
It has now been some time since the release of the updates ISO 9001 and ISO 13485. There was some discussion in this group about how many medical device manufacturers maintain both ISO 9001:2008 and ISO 13485:2003 certification.It would be really goo...
Hyemi Shin (신혜미,차장)
Principal Quality Systems Specialist at Medtronic Korea
Hello, i'm working in spinal implant manufacturing company. DHF formalises input, output, verification, validation, review and transfer. After post production we continue to create revised DHF for design changes. Our DHF is system based e.g. Cervical...
Chief Quality Officer
Hi everybody! Can someone tell the difference between the sentences: 1- " shall document a procedure" and 2- "shall document procedures"? Does 1 mean that we need to implement one procedure per subject ( internal audit, control of documents..) and 2 ...
Ship & Print Your FDA eCopy
Most regulatory experts work on medical device OR in vitro diagnostics--not both. Making the switch from one type of 510(k) to another is not that hard.First, the submission content and format requirements are the same. There are still 20 sections, a...
Senior Quality Engineer/Medical Devices/CSSBB
As per process validation definition in ISO-13485 and FDA CFR 21 Part 820 I have a concern where help from groups members is really appreciated,Recently I read a procedure that states that, since regular lots size are too big, sampling can be conduct...
Dear All.... Could anyone please let me know the procedure for "how to select and contact a Notified Body?"
Technical Operations leader at Insulet Corporation
Thank you for your time and congratulations on your involvement in Medical Devices. I am writing because I am considering a shift in career toward medical device manufacturing. My background is management of high-tech/computer manufacturing and test ...
Quality Assurance Manager at Entellus Medical, now a part of Stryker
I want to ensure we maintain conformance to 820.80 and also incorporate the risk-based approach to acceptance activities. We are looking for potential opportunities to reduce or eliminate inspections based on the item such as supplies vs raw material...
🔥 Find me at MedicalDevicesGroup.net 🔥
Wound Dressing Manufacturers – FDA will be reclassifying your devices. Speak now before October 20, 2016 or forever hold your peace (at least until the proposed rule making)If your company manufacturers wound dressings containing drugs under the FRO ...
Juan Ángel Gracia García
Technical Director Medical Device Department
Under the European Regulation there are many cosmetic products with very low amounts of acidic components (such as glycolic acid, trichloroacetic acid, salicylic acid, lactic acid, etc).Active ingredients in higher concentrations (such as in the case...