Posts by Vesna Janic

This is the third blog in series of three that cover our recent experience with FDA inspection of our Quality Management System (QMS) and 2 medical devices that are contracted to StarFish Medical manufacturing. The first blog outlined our inspection preparation strategies (very different for each one!), the second discussed inspection outcomes, and this blog will cover lessons learned.

This is the second blog in series of three that cover our recent experience with FDA inspections of our Quality Management System (QMS) and 2 medical devices that are contracted to StarFish Medical manufacturing. The first blog outlined our inspection preparation strategies (very different for each one!), while this one discusses inspection outcomes. The last blog will cover lessons learned.

StarFish Medical recently worked with Larry Spears, Former Deputy Director FDA/CDRH Office of Compliance and FDA Investigations, as part of our ongoing efforts to improve and train our quality practices. During our breaks, I spoke with Larry about life after the FDA, how firms can best prepare for regulatory submissions, and the new open nature of the […]

Recently the FDA posted two draft guidance documents that outline FDA current thinking about low-risk devices intended to promote general wellness and the risk classification approach to medical device accessories. I previously wrote about the general wellness draft guidance.  This blog analyses the FDA  medical device accessory draft guidance.  In both cases, less regulatory burden […]

On Friday, January 16, the FDA posted two draft guidance documents that outline their current thinking about low-risk devices intended for general wellness and medical device accessories. Less regulatory burden will make a huge impact on the ability of low risk devices inventors to bring product to market faster and cheaper. This blog analyses general […]

Last week StarFish Medical’s Registrar, Intertek, announced their application for recognition as an Auditing Organization (AO) under the Medical Device Single Audit Program (MDSAP). They hope to complete this process by the end of 2014. For the program to be successful, it is essential that medical device companies volunteer to be audited to MDSAP requirements […]

On January 15, 2013 the Food and Drug Administration (FDA) published an updated list of standards the Agency recognizes for use in premarket reviews of medical devices. This publication, entitled “Modifications to the List of Recognized Standards, Recognition List Number: 030” will assist manufacturers who choose to declare conformity with consensus standards.