Regulatory support
for assured performance

Meeting global standards

Our project teams are fully versant in the process of meeting regulatory standards and are particularly experienced at managing projects in the highly regulated medical sector.

For medical devices, we have a specialist regulatory consultant and we work with safety and performance test houses around the world to suit the needs of the project.

Our regulatory services include:

• Regulatory submissions for medical devices to CE and FDA
• Safety & performance testing to CE, Class 1, Class 2A and Class 2B
• Design history documentation
• Risk analysis
• Clinical trials support
• Product certification.