Hardware Podcasts

021 - "Options" with Karandeep Singh Badwal

Let's Combinate · 23 Feb 2022 · 1h 03m

What this episode covers

Karandeep Singh Badwal, a QA/RA consultant and host of The MedTech Podcast, explains how defining 'intended use' determines whether a product is a regulated medical device or unregulated software, a critical distinction for startups. He details the specific regulatory challenges of Software as a Medical Device (SaMD), including cybersecurity, GDPR compliance, and the impact of the EU MDR on software classification. Badwal also discusses the strategic advantages for UK software companies post-Brexit, where they can still self-certify as Class 1 devices while EU counterparts face stricter notified body audits.

Most relevant to

early-stage companies and companies scaling up

Topics

Mentioned

Products
Proximie
Also
The MedTech Podcast, Eudamed, MHRA, FDA, MDR, MDD, ISO 13485, GDPR, Robert Green, 48 Laws of Power, The 50th Law, Daily Laws

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