Our consultants have over 20 years of experience working in the medical device industry with global regulators, notified bodies and leading international medical device companies. Our company has a network of consultants and specialists that will be able to cover every aspect to enable you to bring your medical device to market.
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Highly experienced consultants
Our consultants have a wealth of industry experience that covers global regulations such as the UK, Europe and the US.
Wide range of expertise
Our team has knowledge and understanding of a wide variety of medical devices and specialist areas. These include cardiovascular devices, orthopaedic devices, animal tissues, drug/device combination, risk management and sterilisation.
Tailored support
No two clients (or their products) are completely alike, which is why we always aim to offer a personalised service, catering to your regulatory and auditing needs.
We can support with:
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Regulatory strategy for bringing products to UK, European and US markets.
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Regulatory intelligence
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Technical documentation
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Clinical evaluation including ISO 14155, and PMCF
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Risk management, ISO 14971
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Medical device usability, IEC 62366
For professional regulator compliance and support, choose Maynard Regulatory Consultancy
Email our team at admin@maynardregulatoryconsultancy.co.uk.