Medical Device Consultancy

Experienced medical device consulting services

Due to the ever-increasing complexity of medical device regulatory requirements and the associated dearth of suitably experienced regulatory personnel, more and more organizations are looking to supplement their staff with a medical device consultant or consultancy.

So, whether you are looking to complete a particularly complex development, cover a gap in resource or just get additional input into a project then Insight Regulatory Consultancy Ltd can help.

Medical device consultancy experience & benefits

We are a small and dynamic medical device consultancy, meaning we can offer a more tailored and dedicated approach with shorter lead-times and lower costs than a lot of larger consulting companies. In addition, each consultant has extensive knowledge and experience in both medical device regulatory and quality requirements and can draw upon the same within the rest of the team, leading to more complete services than individual medical device consultants could provide.

Regulatory & quality system requirements

As a medical device consultancy, we understand that it is critical to remain up-to-speed with the latest regulatory and quality system requirements, such as the EU medical device regulations (MDR and IVDR), so that is why we invest heavily in training and development, while daily reviewing developments from the most relevant organizations such as the European Commission, the MHRA and the FDA.

Medical device risk assessment

When providing medical device consulting services, we always keep risk assessments at the center of what we do, not only in terms of the risk management requirements for medical devices that are interwoven into the regulatory and quality system requirements, but also in terms of the business risks to the client coming from the consulting services provided.

We have extensive experience in working with most regulatory agencies across the world, as well as all of the better-known EU notified bodies such as BSI and TÜV SÜD.