Question
Hiwhat are the rules/cost/time please around a "same as" CE marking application form? in Europe, for a medical device product with CE marking for a cosmetic surgery usage: I would need to change the name (can I use any name?) of the very same device ...
During the next three years I guarantee that every single medical device manufacturer will eventually become sick and tired of hearing the phrase “risk-based approach.” I’ve been there for about 5 years, but there are a few new updates to the standar...
Think it's easier to launch in Europe with a CE Mark and get FDA clearance later? Then you'll want to attend http://medgroup.biz/New-CE-Marking-Rules, a free webinar we're hosting for group members on October 6. The latest adopted draft says you'll n...
ISO9001:2015 + Context of the organization + relevant interested parties needs and expectations (Like the FDA / MDD / etc) can very well be equated to ISO13485. So why at all we need the ISO13485 in a new release that will be still old ... ?source: h...
Bradley Merrill Thompson, RAC
Medical Device, Digital Health and Combination Product Regulatory Attorney
September 2015
In this paper, I outline in detail the structural biases against anything new in the medical technology realm, including novel software. I wholeheartedly support FDA regulation of risky technology, but the law places disproportionately large regulato...
*This is not professional advice.* In fact, it's borderline irresponsible, but here goes. So I was talking to this guy who found me from the group. To protect his anonymity, I'll be vague about his selling proposition. He told me he's building an app...
This is one of my better posts. You'll want to bookmark and share it. And you'll want to watch http://medgroup.biz/substantial, a 19-minute compilation from 2014's 10x Medical Device Conference. It features Ed Black, Tom KraMer, Pat Kullmann, Doug Li...
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...
How common are random FDA audits for device manufacturers? Does the FDA focus mainly on class 3 device companies? Do they ever randomly audit contract manufacturers? Can anyone share any insight into this topic for me? As always I appreciate your com...
"Cybersecurity isn’t just a design issue. It’s not just at product launch. It’s a life cycle issue. It requires a change in mindset." So said FDA’s Suzanne Schwartz, MD, MBA, the Director of Emergency Preparedness/Operations and Medical Countermeasur...
