Posts by Vesna Janic

Vesna Janic

The MDR Deadline is Approaching – Are you prepared?

16 Issues you need to consider May 2020, the Medical Device Regulations implementation day (MDR Deadline), seems far away. But if you are already selling, or planning to sell, medical device(s) in the EU market, you should be well into figuring out what changes you need to make in your Quality Management System.

Vesna Janic

When do you need a Quality Management System (QMS)?

“When do I need a Quality Management System (QMS)?” is the most common question that we get asked by new clients who are just entering into the medical device field. The answer depends on your target market and your exit strategy. To be frank, it is somewhat a chicken and egg thing.

Vesna Janic

17 Lessons learned from 3 FDA inspection strategies and results

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.

Vesna Janic

FDA inspection results from 3 different preparation strategies

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.

Vesna Janic

Advice from a former Deputy Director FDA/CDRH Office of Compliance and FDA Investigations

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 […]

Vesna Janic

StarFish analysis: Medical device accessory draft guidance

Recently the FDA posted two draft guidance documents that outline FDA current thinking about low-risk devices intended to promote general wellness and the risk classification approach to medical device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 I previously wrote about the general wellness draft guidance.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 […]

Vesna Janic

Great News for manufacturers of Medical Device Accessories and products intended for general wellness!

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 […]

Vesna Janic

Faster Market Access for Less: Medical Device Single Audit Program (MDSAP)

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 […]