Question
We're a small medical device (IVD) manufacturer and we're trying to find a suitable PLM system to help us manage our device design and manufacturing.We've already looked at Arena Solutions, Propel, Oracle Agile, and Upchain plus several others that d...
You know that nice, little Medical Device Directive (the MDD) you've been using for 20 years to get a CE mark? You know it's going away, right? Zero MDD certificates will be issued after May 25, 2020. And since CE marks need renewing every five years...
Can you explain what Article 22: System and procedure packs of EU MDR means?What, exactly, do we do to comply with this article?
I've been hosting 10x Medical Device Conferences for six years but no one – before Bob Marshall – sang on stage. You likely recognize Bob's name if you subscribe to his extremely popular Med Device Online site where he serves as Editor in Chief. I ci...
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...
I'm new to my orthopedic implants and associated instrument company and inherited a 510(k) in review. In this 510(k) and those cleared in the last year, we had no discussion on usability 62366-1. We also didn't discuss evidence for biocompatibility b...
Long-time readers won't be surprised that my dear friend, regulatory expert Robert Packard is offering to teach an FDA pre-submission workshop for free. In fact, the last time we held this workshop – some 3½ years ago – more than 1,500 members regist...
Hi Everyone, We're new to the FDA medical device, and we're looking to implement an eQMS system into our workflow. We've looked at Greenlight Guru, MasterControl, and Enzyme. Was hoping to get some feedback from the folks here regarding the pros/cons...
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...
I'm based in India and would like to understand the overall regulatory workflow for medical device product development. What are the documents I need to create for entry into the US market? I've started on our 510(k). Do I need to have GTIN and GUDID...
