Sr. QA/RA Expert at Physio-logic Ltd.
Our product received CE certification. In addition to the product labels and IFU, We would like to indicate in our product' catalogue the CE Marking with N.B number. Is it allowed? Please explain/Make citation.Thank you.source: https://www.linkedin.c...
Hyemi Shin (신혜미,차장)
Principal Quality Systems Specialist at Medtronic Korea
Hello, I am working in local medical device importing company. I'd like to listen to your experience and opinion about Application of ISO14971 to the Sales site independently. We are not a manufacturer and there are no local regulation or obligation ...
Like many of you, I have been slogging through the Practical Guide to ISO 13485:2016 since it came out end of September. To be honest I found it anything but practical. The guidance is a behemoth at 214 pages, contains circular references with vague ...
Just after Halloween, the FDA issued a Consent Decree to Philips Healthcare for a number of egregious violations involving their external defibrillators. Philips had “tricked” industry by consistently providing unsafe defibrillators so the FDA “treat...
VP of Marketing at Greenlight Guru
Did you know that every year since 2010 the #1 reason medical device companies receive FDA 483's is poor CAPA procedures? Here's a best practice guide to help you implement a best practice approach to CAPA while avoiding the common pitfalls → https:/...
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 ...
Regulatory Affairs for Medical Devices
Hello all,Do you know if the FDA can inspect your emails if you used email as a record as a proof of compliance?Thankssource: https://www.linkedin.com/groups/2070960/2070960-6326393967122489345
QA consultant at Avital Arbel QA services
Hi all. does anybody know how one can find out which NBs have already been accredited? I know BSI have, they naturally boasted being the first ones. but is there some list or do I have to screen the NANDO? source: https://www.linkedin.com/groups/2070...
Group member Roger Cepeda wrote an informative (and cleverly worded) piece at https://medgroup.biz/RWE called "FDA’s Guidance on Real-World Evidence for Medical Devices: Great for Class III Registry Participants, But What About the Rest of MedTech?" ...
Ship & Print Your FDA eCopy
The release of the FY 2018 FDA user fee schedule was delayed until the end of August, because the re-authorization of user fees was not approved until August 18, 2017. For PMA submissions and related supplements there is a 33% increase. For 510(k) su...