Our Team
Heidi
Heidi has spent her career on both sides of the regulatory table, as a senior assessor within one of Europe's largest Notified Bodies, and as a hands-on regulatory advisor to the manufacturers seeking approval. That dual perspective is rare, and it is the foundation of everything CliniQual does. She knows what regulators actually look for, not just what the guidance documents say they look for. There is a considerable difference between the two.
Her speciality is the cases other people find difficult. She works extensively with developers of novel devices where no defined regulatory pathway exists. She builds the approach from first principles, taking it end-to-end from early concept through to approval, and personally drafting the critical documentation rather than delegating it. When regulatory risk becomes a business risk, she works directly with Boards and senior leadership teams.
Her core expertise sits in clinical and performance evaluation, which is the point at which most devices fail certification. In her experience, this is rarely because the technology is weak. It is almost always because the evidence strategy is fragmented, not defensible, or was built too late. She specialises in defining endpoints, benchmarking against the state of the art, and ensuring the regulatory argument stands up as a coherent whole rather than a collection of documents in a folder.
Her track record includes world-first certifications across multiple medical device categories, board-level advisory on regulatory strategy and investment readiness, and the development of training programmes for companies including Abbott and for regulatory bodies including the SFDA in Saudi Arabia. She has spoken at leading medical device conferences internationally.
She has also, on at least one occasion, slept on a client's office floor for more than a week to meet a critical deadline. It is not something she recommends. But when you are racing to secure the world's first MDR certification for a novel device category, you do what it takes.
Mark
Mark's career has been built in environments where governance is not optional, oversight is non-negotiable, and the consequences of getting it wrong are visible at the highest levels. He has advised UK government departments including the Cabinet Office, HM Treasury, the Home Office, HMRC, and the Ministry of Defence. He has provided independent programme assurance on nationally significant initiatives, including the London 2012 Olympic security programme, and has worked with major financial institutions including Barclays and Lloyds on governance and information management at group level.
What connects that body of work is a single consistent thread. In every environment, the programmes that ran into trouble shared the same characteristics: strategic assumptions that nobody had tested, evidence gathered to support a plan rather than to inform one, and governance structures that looked robust on paper but couldn't withstand real scrutiny. Mark has spent his career identifying those patterns early, and building the frameworks to address them before they become crises.
He joined CliniQual because he recognised those same patterns in the medical device sector. The ambition is different. The science is different. The consequences for patients are entirely different. But the underlying governance challenge of how do you build an organisation that can support genuine regulatory and clinical rigour whilst remaining commercially viable and investor-ready, is one he has navigated many times before, in some of the most demanding environments in British public life.
His role at CliniQual is to ensure that clinical and regulatory ambition is matched by sound business planning, clear governance structures, and the kind of independent oversight that turns a strong scientific strategy into a sustainable organisation. He works directly with Boards and senior leadership teams, particularly where regulatory risk intersects with financial planning, investment readiness, or engagement with funding bodies and government.
Technical excellence and governance rigour are not separate disciplines. They are the same discipline, approached from different directions. That is why CliniQual works.
