Hardware Podcasts

What Impact Does a QMS & Regulatory Have on Fundraising and Pre-money Valuation?

Global Medical Device Podcast · 16 Jun 2022 · 48m · Episode 267

What this episode covers

Cristiano Fontana, founder of ThreeBridges and co-founder of CrossBay Medical, explains how Quality Management Systems (QMS) and regulatory strategy directly impact fundraising, pre-money valuation, and market access for medical device startups. He argues that investors evaluate companies based on the reliability of their business plans, the efficiency of their QMS, and their ability to mitigate regulatory risk, which in turn affects cash flow and growth potential. Fontana highlights significant differences in investor expectations and liquidity between the US and EU markets, noting that the EU's MDR has shifted strategies toward targeting the FDA first, while emphasizing that team commitment and coachability are critical factors in securing investment.

Most relevant to

early-stage companies and companies scaling up

Topics

Mentioned

Companies
ThreeBridges, CrossBay Medical, Greenlight Guru, IStarter, ClubDealOnline
Also
MDR, FDA, ISO 13485

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