Quality & regulatory
exceeding standards

ISO13485 quality certified for your peace of mind

In the highly regulated medical industry, our UK and Shanghai teams offer global experience and knowledge of regulatory standards for world markets.

From design and manufacturing to electronics, our regulatory consultants will help you meet regulatory standards including CE and FDA to develop unique products which comply with all applicable laws.

We also work with international safety and performance test houses around the world to support the individual needs of projects.

With ISO 9001 and ISO 13485 certification for IDC, IDC Models and IDC China, we are fully committed to best practice in medical design and development.

Our regulatory services

From many years’ experience developing medical devices and through the IDC quality managed development process, we make sure that the key regulatory issues are addressed at the right time in the project.

Our retained regulatory consultants keep up to date with the latest changes to medical device regulations and requirements and offer peace of mind, as well as in-depth support for regulatory submissions.

Our regulatory support services cover:

• Risk analysis and risk management planning
• Regulatory submissions for medical devices (for different regional requirements including European Medical Device Regulation (CE), FDA 510 (k) and other regional applications)
• Device classification according to device and region
• Safety and performance testing including accelerated ageing, ISO 60601-1-2 and EMC
• Design history documentation
• Technical files compilation and submission
• Clinical trials support
• Product certification.

Integrating with your regulatory team

Many of our clients have extremely experienced and capable teams to deal with their regulatory affairs. We are comfortable working alongside in-house experts and have experience running projects under our clients quality management systems as well as our own.