Posts categorized as“Regulatory”

Alexandra Reid

Pathways to a FDA Approved or Cleared Medical Device

Chutes and Ladders – Commercializing your medical device in the US market requires submitting marketing applications to the FDA to become an FDA Approved or Cleared Medical Device. The content of your FDA submission is determined by how your medical device is classified into one of three Classes (I, II, or II), based on the […]

Nigel Syrotuck

RoHS 2 vs RoHS 3 impact on medical devices

Note: RoHS 3 is a colloquial term referring to Delegated Directive (EU) 2015/863, which is actually an amendment to RoHS 2 (Directive 2011/65/EU) rather than a standalone Directive. Though this terminology has become somewhat common (common enough to keep using the term here), it’s technically inaccurate. Originally published in April 2016, the article is updated […]

Virginia Anastassova

How to benefit from FDA ASCA (Accreditation Scheme for Conformity Assessment) Pilot Program

FDA launched their pilot  ASCA (Accreditation Scheme for Conformity Assessment) Program on September 25, 2020. The intent for the ASCA program is to utilize accredited third-party testing laboratories to assess premarket applicants’ declarations of conformity to consensus standards for safety, performance and biocompatibility. The final guidance outlining the accreditation scheme for the ASCA pilot program […]

Astero StarFish

Our Top 10 medical device development videos in 2020

Our top 2020 medical device development videos include 6 new videos. They join favorites from previous years and cover subjects including 2020 updates, COVID implications for research and POC devices, optimizing founder value, manufacturing for NPI, IVD insights, and working at StarFish.

Astero StarFish

What’s the worst mistake you can make when developing a medical device?

How many have you made? We posed the question, “What’s the worst mistake you can make when developing a medical device?” to our team of engineering, design, quality, regulatory and manufacturing experts. The answers were fast and furious (well, filled with enthusiasm) and in no particular order of importance, May you read and learn from […]

Josh Coutts

Addressing ingress protection for home healthcare medical devices

What the standard says and what you should know. Increasingly medical device technology is filtering down from hospitals and into patients’ homes.  Designers need to understand and address the impact of this transition on the medical device design when addressing ingress protection for home healthcare medical devices 60601-1-11 Collateral Standard: Requirements for medical electrical equipment […]

Virginia Anastassova

FDA Breakthrough Devices Program Update and Advantages

The FDA Breakthrough Devices Program provides several advantages for novel devices that meet the inclusion criteria and can significantly reduce a product’s time to market. The Breakthrough Devices program implemented by FDA in 2018 has superseded the Expedited Access program that was introduced in 2015. The program is gaining popularity with 11 designations in 2016, 19 […]

Deborah Pinchev

COVID-19 Testing Authorizations in the US and Canada

This blog provides an overview of COVID-19 testing authorizations and developments of the COVID-19 pandemic in the United States and Canada. In the world of regulated health care products these tests are known as in vitro diagnostics (IVDs) and fall under the medical device definition in most jurisdictions. Almost 6 months since both the FDA […]

Helen Simons

Submitting a medical device application under the Health Canada Interim Order

Our experience submitting under the Health Canada Interim Order Prime Minister Trudeau announced StarFish Medical’s participation in the  NGEN Canadian Emergency Ventilators project on March 31, 2020, as part of Canada’s Plan to Mobilize Industry to Fight COVID-19. StarFish Medical was asked to help supply ventilators for the Canadian healthcare system and to develop them rapidly so […]

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