We are proud to have a growing number of industry experts who bring experience of quality, regulatory, technical and project management experience, to offer support to the IVD industry.
Our team have developed their knowledge and understanding of the industry in various roles within the manufacturing, design and development of IVDs. This allows us to understand the complexities of quality and regulatory requirements from all areas of the IVD business. Our aim is to provide clear, pragmatic advice that helps non-quality and regulatory professionals understand the requirements.
Our team of experts provide consultancy on many different disciplines, ranging from project-based roles, quality, or technical review or continuous, ad-hoc background support.
To help you learn, understand or develop your existing knowledge of the IVD requirements, we provide IVD training courses on key aspects of the IVD regulatory and quality. A unique part of this experience is the add-on group workshops where we can sit down and talk through your systems, or documents to further expand you knowledge, and really understand how to implement any learnings specific to your business needs.
For non-UK based manufacturers placing devices on the market in the UK, we offer an IVD UK Responsible Person (UKRP) service. We we walk you though the process of device registration and support any vigilance activity required. For IVD SMEs who do not have an established Quality or Regulatory department, we are able to support you to meet the new EU IVDR requirement for a Person Responsible for Regulatory Requirements (PRRC).
We collaborate with a network of like minded companies allowing us to offer a broad level of service to the IVD industry, and we continue to look for opportunities to establish strong connections throughout the industry.