“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.
Posts by Vesna Janic
A couple of nights ago I watched The Bleeding Edge on Netflix. It’s a documentary about medical devices, or rather about side effects of medical devices. If you have not seen it yet, I recommend viewing it.
The 21st Century Cures Act (Cures Act), signed into law on December 13, 2016, is designed to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently.
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.
This is the first blog in series of 3 that will cover StarFish Medical’s recent experience with the FDA inspection of our Quality Management System (QMS) and 2 medical devices that are contracted to StarFish Medical manufacturing.
To check our compliance with US regulations, StarFish engaged Larry Spears, retired Deputy Director of CDRH to conduct an FDA mock inspection of our Quality Management System. The inspection was a great experience for all of us and gave us a good overview of where the FDA investigators would be focused. Not surprisingly Corrective and […]
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Recently the FDA posted two draft guidance documents that outline FDA current thinking about low-risk devices intended to promote general wellness and the risk classification approach to medical device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 […]
Audits and inspections are a regular occurrence in Life Science companies that operate under Health Canada, US FDA, EU MDD, or any other regulations and/or standards. The experience can be very positive or very stressful depending on how well prepared you are. In preparation for an audit/inspection, both parties need to be clear on […]