Posts categorized as“Regulatory”

Azra Rajwani

Big changes in ISO 14971:2019

Changes in ISO 14971:2019 mean a big change to the medical device industry. ISO 14971:2019 was released mid-December, and the EN version was released on December 18, 2019. The last time this standard was released was 2012, so buckle up folks because this new Risk Management Standard is going to be one roller-coaster ride.

Astero StarFish

Top 10 medical device commercialization lessons and tips

We asked our development and commercialization experts to share their top medical device commercialization lessons and tips based upon actual medical device development and commercialization experiences.  Their recommendations cover projects from working at StarFish as well as other medical device organizations.  Many include links to blogs with additional information. Here are 10 ideas to increase […]

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Leveling the Playing Field with recent Draft Guidance   Review and Update of Device Establishment Inspection Processes and Standards, a draft guidance document from the FDA, establishes uniform processes and standards for FDA’s Inspection Process of both domestic and foreign medical device firms.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 […]

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 […]

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