Successfully managing medical device and IVD regulations needs core regulatory expertise along with strong foundations such as Quality Management Systems, trained personnel etc. We work with our partners across these critical areas for success.
We focus on medical device regulatory consulting and in-vitro diagnostic or IVD consulting services. We are a small approachable firm of experts, with the credibility of PhD-level scientists experienced in product development.
Our services span the regulatory life-cycle from strategy through development to global expansion and post-market activities. These are described in the device regulatory services and IVD regulatory services pages.
Our other consulting work has built up to complement the regulatory capability:
A robust quality management system (QMS) is a vital component for developing the best quality products and for demonstrating competence with regulatory bodies.
Development work must be planned, executed and reported in ways that regulatory bodies recognise. This forms a complex mix of regulation, guideline, international or industry-specific standard and accepted practice. Through our experience, we help clients put together strong device development cases. For more detail, please see the Development page.
Audits are key to company approval to do business, but they can be disruptive and stressful. We help clients to reduce this disruption and increase success in a number of ways.
We offer training on regulatory requirements, implementing procedures and ways of working. This helps to align teams to work together effectively as well as ensuring a high standard of work that is carried out and documented.
We provide the UK Responsible Person service to our partner companies from outside the UK. This is a requirement for Medical device approval in the UK and offering this service helps to make UK market entry simpler for our customers.
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