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

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2022-06-16
- Length: 48m
- Episode: 267
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-06-16-what-impact-does-a-qms-regulatory-have-on-fundraising-and-pre-money-valuation
- Listen: https://podcast.greenlight.guru/episode/what-impact-does-a-qms-regulatory-have-on-fundraising-and-pre-money-valuation

## Summary

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.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-06-16-what-impact-does-a-qms-regulatory-have-on-fundraising-and-pre-money-valuation#t=0) Introduction: Etienne Nichols and Cristiano Fontana
- [2:41](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-06-16-what-impact-does-a-qms-regulatory-have-on-fundraising-and-pre-money-valuation#t=161) Cristiano Fontana's Background and ThreeBridges Services
- [5:29](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-06-16-what-impact-does-a-qms-regulatory-have-on-fundraising-and-pre-money-valuation#t=329) How Investors Evaluate QMS and Regulatory Impact on Valuation
- [7:32](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-06-16-what-impact-does-a-qms-regulatory-have-on-fundraising-and-pre-money-valuation#t=452) Building a Reliable Business Plan and Fundraising Strategy
- [13:38](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-06-16-what-impact-does-a-qms-regulatory-have-on-fundraising-and-pre-money-valuation#t=818) Specific Challenges in Medical Device Fundraising
- [18:32](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-06-16-what-impact-does-a-qms-regulatory-have-on-fundraising-and-pre-money-valuation#t=1112) The Critical Role of QMS in Reducing Investor Risk
- [23:07](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-06-16-what-impact-does-a-qms-regulatory-have-on-fundraising-and-pre-money-valuation#t=1387) Differences in Fundraising: US vs. EU Markets
- [28:20](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-06-16-what-impact-does-a-qms-regulatory-have-on-fundraising-and-pre-money-valuation#t=1700) Impact of EU MDR and FDA-First Strategies on Valuation
- [33:36](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-06-16-what-impact-does-a-qms-regulatory-have-on-fundraising-and-pre-money-valuation#t=2016) Factors Impacting Exit Success and Dilution
- [43:13](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-06-16-what-impact-does-a-qms-regulatory-have-on-fundraising-and-pre-money-valuation#t=2593) Valuing the Team and Commitment

## Topics

- [Fundraising & investors](https://hardwarepodcasts.com/topic/fundraising)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Pricing, margins & unit economics](https://hardwarepodcasts.com/topic/pricing-and-unit-economics)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)

## Most relevant to

early-stage companies, companies scaling up

## Mentioned

- ThreeBridges (company)
- CrossBay Medical (company)
- Greenlight Guru (company)
- IStarter (company)
- ClubDealOnline (company)
- MDR (other)
- FDA (other)
- ISO 13485 (other)

## Related episodes from other shows

- [128 - Former FDA Inspector and Managing Consultant, Vin Cafiso: Cadavers/Autopsies, Tales from FDA Inspections, Understanding the QMSR, and Quality Culture](https://hardwarepodcasts.com/podcast/lets-combinate/2024-03-20-128-former-fda-inspector-and-managing-consultant-vin-cafiso-cadavers-autopsies-t) (Let's Combinate)
- [S6E19 Stuart Grant | MedTech Innovation](https://hardwarepodcasts.com/podcast/being-an-engineer/2025-05-09-s6e19-stuart-grant-medtech-innovation) (Being an Engineer)
- [015 - "Would You Use it on a Family Member?" with Monir El Azzouzi](https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-19-015-would-you-use-it-on-a-family-member-with-monir-el-azzouzi) (Let's Combinate)
- [244 - 5 Critical Quality Differences Between Drugs and Devices](https://hardwarepodcasts.com/podcast/lets-combinate/2026-07-01-244-5-critical-quality-differences-between-drugs-and-devices) (Let's Combinate)
- [031 - "The Five Stages Of Regulatory Grief" with Michelle Lott](https://hardwarepodcasts.com/podcast/lets-combinate/2022-05-04-031-the-five-stages-of-regulatory-grief-with-michelle-lott) (Let's Combinate)

## Citing this page

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