Regulatory risk is a leadership issue, not just a technical one
In IVD and diagnostics companies, regulatory, quality, and clinical decisions made early have long-term consequences. Too often, these decisions are treated as technical tasks rather than strategic choices until they become a problem during funding, diligence, or scale.
EmRQ exists to bridge that gap.
We provide senior-level insight at the intersection of regulation, quality, and clinical evidence, helping leadership teams and investors understand where risk truly sits, what decisions matter most, and how today’s choices affect future value.
Please contact us if you cannot find an answer to your question.
Start-up senior leaders preparing to raise or scale. For early and growth-stage IVD companies, regulatory and clinical assumptions are often stress-tested for the first time during fundraising or partner discussions. EmRQ helps senior leaders pressure-test these assumptions early, understand where real risk lies, and make informed strategic choices before scrutiny increases.
Boards & Scale-Ups. As companies grow, regulatory and quality risk becomes a governance issue. EmRQ supports boards and senior leadership with independent insight to inform strategic direction, investment decisions, and long-term value protection.
Investors. EmRQ works with investors to translate regulatory, quality, and clinical complexity into clear business risk and decision signals supporting portfolio oversight, investment decisions, and post-investment de-risking.
Engagements are focused, senior, and advisory in nature. EmRQ does not act as an outsourced regulatory or quality function. Instead, we work alongside leadership teams to provide strategic oversight, challenge, and clarity at moments that matter.
Where executional support is needed, EmRQ introduces the appropriate CRO or execution consultants where needed.
With over 24 years of experience in Quality, Regulatory, and Clinical Affairs within the In-Vitro Diagnostic (IVD) and Medical Device industries, I have a deep understanding of the entire product pathway, from development and regulatory compliance to post-market surveillance. With previous experience in the public healthcare sector laboratories, I also understand the importance of getting awesome innovations out there to patients.
+44 7470 375310
Director emmabarringer@emrq.co.uk Business Development Manager willbarringer@emrq.co.uk