Regulatory Guidance
We have extensive experience helping clients understand the roadmap to regulatory approval in different markets. It is an essential part of any business plan for a new medical technology. Developing the right regulatory strategy enables you to get your products to market quickly by achieving compliance with UK, EU, US and other international standards.
Regulatory Roadmaps & Strategy Reports
We provide relevant, up to date and bespoke guidance and roadmaps on the latest regulatory requirements for medical devices, IVDs and digital health products. Our services include:
- Determining medical device classification and providing roadmaps on the process and guidance to gain regulatory approval. Roadmaps include both an overview of the medical device/IVD regulations which apply in different markets (Great Britain, Northern Ireland and the European Union, the USA) and summaries of the roles and responsibilities of Competent Authorities, Notified Bodies/UK Approved Bodies and other Economic Operators, including Manufacturers, Authorised Representatives (EU) and/or UK Responsible Person, as well as Importers and Distributors.
- Comprehensive strategy reports which give bespoke advice on medical device classification as well as the process and documentation required to achieve regulatory approval in the UK, EU & USA.
- Guidance on data protection and data security regulations, as well as clinical risk management and clinical safety standards for digital health products in the UK.
In partnership with our Medical Regulatory Associates, we are also able to provide:
- Dedicated regulatory services to achieve for compliance with UK and EU MDR/IVDR, FDA and global regulatory requirements.
- Development of Quality Management Systems to meet European, US and International standards (ISO 9001 / ISO 13485 / FDA Quality System Regulation).
Human Factors
The application of Human Factors, or Usability Engineering processes, into the development of medical devices, leads to safer and more intuitive products, as well as facilitating the regulatory approvals process, so accelerating the adoption and spread of innovative medical technologies. HTE is able to guide you through this process and conduct the required testing and assessments
HTE can help with the iterative process where design concepts, prototypes, and final products are assessed and reviewed by the intended users, which can include clinical or operational staff, as well as patients and carers.
Health Tech Enterprise is an independent provider of Human Factors services, conducted under IEC 62366-1:2015/AMD 1:2020. Typical services include:
- Working with Health Tech companies to help plan and implement usability studies, identifying device user profiles, use environments, possible use errors, as well as identifying and assessing realistic use scenarios and clinical tasks.
- Designing and Conducting Formative Evaluations. Formative Evaluations reduce risks in the design and development phase, as well as provide an opportunity to review preferred design concepts, layouts and formats. These studies, conducted with the intended users (clinicians and/or patients), examine use errors in identified tasks, review risks and safety implications, as well as assess the innovation’s overall ease of use.
- Designing and Conducting Summative Testing. Usability testing of final products and product documentation (e.g. user manuals & IFUs) which is required when compiling technical files for final regulatory approval prior to product launch.
