Regulatory Support

Adhering to regulatory requirements is a key part of any medical device development project. It is a complex process with multiple steps that need to be followed to ensure compliance.

The Medical Device Regulation (EU 2017/745) has added to the complexity, so consulting the experts is vital to avoiding setbacks later on. If you don’t have the in-house regulatory expertise you need, then we are an ideal cost-effective option.

Helping you

Our team can provide regulatory support and advice across the total product development and commercialisation cycle.

This includes helping you to:

  • Generate all the technical data you need to submit as part of the technical file for the medical devices regulation.
  • Ensure you know how to comply with the new Medical Device Regulations necessary to go to market in the UK and EU marketplace.
  • Produce documentation and manage the CE mark process with your notified body.
  • Ensure your clinical investigation or performance study includes the right end points to meet your CE mark requirements.
  • Carry out classification reviews and gap analysis against the essential requirements.
  • Review existing documents and processes.

World class experts on hand to support your project

Whatever support your project needs, we’re here to help its development. Let’s move things forward, together.

Our unique approach

Expert partners

Our internal expertise is enhanced by the knowledge of our partners.

The Centre for Healthcare Equipment and Technology Adoption (CHEATA) is our main regulatory partner and they can cater their advice and support to meet the needs
of your company.

Our pre-existing relationships with these partners will make it easier for you to
access their knowledge.

We will work with them to offer you a bespoke service that focuses on your regulatory needs and makes the whole process less time consuming and laborious for you.