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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...
ISO 13485 medical device, AS9100, AS9120 aerospace and ISO 9001 QMS consultant & lead assessor QA/RA Manager at Montmed
Hello everyone, what are the requirements for selling first aid kits in USA?The first aid kits will include medical gloves, BZK swabs and alcohol prep pads and the suppliers of each will be FDA approved for these products.What needs to be done to get...
regulatory engineer presso Lima Corporate
I have a question on MDR implementation: Is it confirmed that custom-made devices are exempt from CE marking?According to MDR art.20 par.1, and art.52 par.8, I believe that custom-made devices are exempt from CE marking. Are there any conflicting int...
Ong Kean Seng
Senior Manager Regulatory Affairs at InQpharm
I just came across a legal manufacturer in EU with CE Certificate granted to their devices but without having ISO13485 certificate.I ran through MDD 93/42/EEC and it seems there is no stated requirement that a legal manufacturer needs to obtain certi...