Posts categorized as“Regulatory”

Alexandra Reid

Bringing Consistency to the FDA’s Inspection Process

Leveling the Playing Field with recent Draft Guidance   Review and Update of Device Establishment Inspection Processes and Standards, a draft guidance document from the FDA, establishes uniform processes and standards for FDA’s Inspection Process of both domestic and foreign medical device firms. The FDA’s plan is outlined in a short, six-page document released March […]

Virginia Anastassova

510(k) submission: 9 Tips for success

A 510(k) submission is required in the U.S.to receive clearance to market almost all class II medical devices.  While the 510(k) preparation process is not as onerous as preparing a Premarket Approval (PMA), it has its own challenges and pitfalls. We recently completed a 510(k) submission and I’d like to share some of the wisdom […]

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.

Astero StarFish

5 tips for a productive EMC lab visit

EMC (Electromagnetic compatibility) compliance is an essential requirement for all electronic medical devices. Usually, designers partner with EMC labs (certified testing) facilities in order to assess device compliance. In this blog members of the StarFish Electrical Engineering team share tips for a productive and successful assessment during your EMC lab visit.

Adam MacNeil

5 EMC Testing beginner’s tips and tricks you’ll want to know

Electromagnetic Compatibility (EMC) testing is a key part of device development for medical or other devices. It consists of two different sets of tests: Emissions testing, and immunity testing. As you might guess from the name, emissions testing looks at the electromagnetic emissions from the device under test (DUT), while immunity testing looks at what […]

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.