Hardware Podcasts

Common QMS Mistakes SaMD Companies Make

Global Medical Device Podcast · 21 Oct 2022 · 45m · Episode 285

What this episode covers

Karandeep Singh Badwal, founder of QRA Medical, explains common Quality Management System (QMS) mistakes made by Software as a Medical Device (SaMD) companies, emphasizing that validation must cover all software used in the QMS, not just the device itself. He highlights the frequent failure to treat cloud platforms and software tools like Trello or AWS as controlled suppliers, and the oversight of patient data as customer property. Badwal also stresses the importance of defining deputy roles for key personnel and tailoring procedures to specific jurisdictions like EU MDR and UK regulations.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
QRA Medical, Greenlight Guru, BSI
Products
Trello, Amazon AWS
Also
ISO 13485, EU MDR, UK MDR

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