Hardware Podcasts

003 - “Standard Understanding” with Mark Swanson

Let's Combinate · 20 Oct 2021 · 54m

What this episode covers

Mark Swanson, President of QRx Partners, discusses his extensive background in medical device quality, including his work on the ISO 13485:2016 revision and ISO 9001:2015 standards. He explains the consensus-driven process of writing international standards, highlighting the semantic challenges of terms like 'and/or' and the specific risk definitions in medical device regulations versus generic business standards. Swanson also details the practical implications of ISO 13485 certification for small to mid-sized companies, weighing the $30,000 annual cost against regulatory requirements and market access.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
QRx Partners, Medtronic, AAMI, ASQ
Also
ISO 13485, ISO 9001, Traction

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