An independent reviewer is required for Design Reviewes. The problem in small start-up companies is that everyone is involved in the process and no one is really independent, on the other hand an external consultant may be very expensive for those co...
M.D., Ph.D. Pediatric Cardiologist, Professor of Pediatrics
Why I ask this? As a physician sometimes I have a feeling that in this group I'm not at home because it's mainly a group of businessmen, salesmen, distributors, engineers and others outside health practice with quite another way of thinking. Many of ...
HiI am curretly updating our internal SOP's after a notified body audit found that we did not comply with the latest version of the ISO 14971 2012 Std. Specifically, I am interested in how others have updated SOP's to comply with Annex ZA and how thi...
Analyst and scientist for biotech investment
Hi all, I am looking for a simple protocol to file a 510k exempt device to FDA, since FDA provides so much detailed information of 510k and PMA on the website. I will be grateful if someone could share some simple tips of what I should do for the 510...
Ship & Print Your FDA eCopy
The most common nonconformity identified by reviewers of a CE Marking submission is an inadequate or missing clinical evaluation report (CER). Preparing a CER is time consuming, but if you have a good protocol and procedure the process does not need ...
Senior Manager Regulatory Affairs-CMC at Alexion Pharmaceuticals, Inc.
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...
Regulatory Affairs & Quality System
Can you explain what Article 22: System and procedure packs of EU MDR means?What, exactly, do we do to comply with this article?
Quality and Compliance Engineer at Ushio America, Inc.
Dear all, Does EU call out a specific amount of years an electromechanical medical device is required to last in its lifetime?Any comments or links to information would be greatly appreciated.Kind regards,Tomsource: https://www.linkedin.com/groups/20...
Dr Kalina Tonigold
Regulatory Affairs & Quality Management Specialist at ARRI
Hi all,I was wondering what exactly a Qualified Person (QP) in the field of medical devices does and means? According to some sources which I am reading, it says “Manufacturers shall have available within their organization at least one qualified per...
"Hip, hip, hooray! There's a new CPT code! I'm going to get paid!" you gleefully exclaim. "No you're not," health economist Nic Anderson said in this exceptionally valuable $350 consultation. I'm sharing approved, redacted portions of our call (yours...