ISO 13485:2016

Posts tagged with “ISO 13485:2016”

Nick Allan

10 things I learned from Bad Blood

What Yeast, Richard Nixon, a CIA agent, a Teenager, Donald Trump and $9 billion dollars have to do with a Fake Medical Device Bad Blood: Secrets and Lies in a Silicon Valley Startup was at the top of my 2018 summer fun reading list.  It was released in May 2018 and written by John Carreyrou (the two […]

Astero StarFish

Top 10 StarFish Medical videos of 2017

We love creating StarFish Medical videos to help viewers learn about medical device design, development and manufacture.  We also appreciate the opportunity to showcase our talented team. It’s a great way to get a better sense of the people you will be partnering with at StarFish. The top 10 viewed Starfish Medical videos for 2017 […]

Kathryne Young

Establishing Supply Chain Controls to de-risk your supply chain

As a medical product moves through development to production stage, establishing  supply chain controls to ensure reliable suppliers is critical to satisfy regulatory requirements for your device. ISO 13485:2016 has specific language around supplier controls that needs to be addressed in your QMS. It includes the additional requirements of supplier performance evaluation and controls appropriate […]

Michael May

How ISO 13485:2016 changes will impact your QMS (sections 4-6)

With the March 1, 2016 release of ISO 13485:2016, medical device developers and manufacturers have been given a three year grace period to implement changes from the previous 2003 version. During those three years both the 2016 and 2003 versions will be valid to operate under; however after the three year grace period, compliance with […]

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