TRaC’s experts (scientists, engineers and regulatory advisors) understand the challenges of exporting medical products to the global market. We help manufacturers achieve increased speed to market and successful product launches by providing the following regulatory affairs consultancy services:
- Bespoke training
- Managed test programs
- Planning and support
- Documentation review and assessment
- Managing products and QMS approvals
We assist manufacturers of electrical medical devices from the conception of their products with our Early Stage Qualification (ESQ®) services. Using our expertise from verifying thousands of different products every year and our industry-leading certification and approvals experience, we can provide manufacturers with the ability to identify the appropriate testing standards and remove both cost and risk out of the product validation process.
TRaC is UKAS accredited to BS EN ISO/IEC 17025:2005, approved by LRQA to ISO 9001:2008, a National Certification Body (NCB), and a Certification Body Test Laboratory (CBTL) under the IECEE’s Worldwide System for Conformity Testing and Certification of Electronic Equipment and Components.
Across our six UK testing centres we provide expertise and testing services for medical devices, including:
- EMC Testing
- Safety Testing
- Radio and Wireless Testing
- Battery Testing
- Environmental Testing
- Microbiological Testing
We typically provide medical regulatory testing and test reports to the European EN60601 and 510(k) from the United States, which are the core standards of medical product verification. Our medical approvals services can help manufacturers gain access to 167 different countries by providing guidance on:
- CE Marking
- FDA QSR
- ISO 13485
To learn more about how our Medical Device Testing and consultancy services can add value to your design and testing, email your specification and requirements to email@example.com, enter your details into the blue form or call us on the number in the top right corner of this page.