Our Medical Safety Testing & Certification Capabilities »
- NRTL (Nationally Recognized Testing Laboratory) recognized by the Occupational Safety and Health Administration of US (OSHA) for
- IEC/EN 60601-1 3rd Edition
- UL 60601-1
- AAMI ES60601-1
- CSA C22.2 No. 601.1
- Electrical wheelchairs to ANSI/RESNA/FDA/EN requirements including RESNA WC-1:2009.
- FDA devise submissions for FDA clearance
- Complete testing for active implantable devices (ISO 14708)
- National Certification Body (NCB) & Certification Body Testing Laboratory (CBTL) testing & certification for Medical Electrical
- Medical Device Battery Safety Testing
Your Global Testing Partner for Notified Body Services and Global Approvals »
With 16 laboratories in North America, Europe and Asia Pacific, Eurofins offers regulatory compliance expertise and experienced GMP/GLP/ISO 17025 testing to ensure rapid turnaround times with the highest level of service, and most advanced technologies for your analytical chemical, microbiological, biocompatibility, electrical, mechanical and package testing needs.
Our international presence ensures a unique global breadth of harmonized capabilities to solve all of your testing challenges and guide you through the complex regulatory landscape to help you develop the optimal strategy for your medical device testing needs.
Notified Body Services:
• Type Examination (Annex III): – EC certificate showing conformity of the Medical Device examined (type) with the essential requirements established in the directive.
• EC Verification (Annex IV): – EC certificate that guarantees and declares that the production batch(statistical verification) or each product (individual verification) conforms to the type certified and to the applicable requirements of the directive.
• EC Declaration of Conformity: – Guarantee of quality of the manufacturing process or of the product (annexes V-VI), the certificate that guarantees and declares that the quality system, with regard to sterility, is applied and complies with the requirements of the directive.
Other Related Services:
- Chemical / Physical Analysis
- Microbiology & Sterility
- Packaging & Seal Integrity
- Combination Products
What is Medical Device Safety Testing?
Medical device safety testing involves evaluating a medical device’s compliance to IEC 60601-1 3rd Edition, the internationally harmonized safety standard used for all electronic medical devices. There may be additional requirements for full safety compliance, such as those set forth by the FDA and other regulatory bodies within various countries, but the basic requirements for medical device safety testing will be found in the IEC 60601-1 3rd Edition Document. According to the 60601-1 3rd Edition, medical devices will be evaluated to protected against:
- Electrical Shocks
- Mechanical Hazards
- Unwanted and Excessive Radiation
- Ignition Hazards
- Abnormal Operation and Faults
- Constructional Defects