EU Medical Device Regulation (MDR) Certification

Applus+ Laboratories

Barcelona, Spain

Applus+ Laboratories is a leader provider of comprehensive testing and certification services , supporting manufactures and industries in ensuring the safety, quality, and performance of their products. Headquartered in Barcelona, Spain, we operate a global network of multidisciplinary laboratories across Europe, North America, and Asia, serving industries such as medical devices, aerospace, automotive, electronics, cybersecurity, and renewable energies . We offer a robust portfolio of medical device testing services including: Biomechanical and chemical testing (including biocompatibility) Packaging testing EMC and electrical safety Cybersecurity assessments Specialized testing for implants and dental devices Our laboratories are accredited to meet regulatory requirements in key global markets, including FDA (USA) and NMPA (China). In Europe, we provide a complete regulatory pathway through our two Notified Bodies (NB 2764 and NB 3121) , designated under the Medical Device Regulation 2017/745 (MDR). Applus+ Laboratories is also accredited under ISO/IEC 17021-1 to certify Quality Management Systems in accordance with ISO 13485, serving the medical device sector. This integration of global testing infrastructure with expert regulatory certification enables Applus+ Laboratories to offer a one-stop-shop solution for medical device manufacturers — supporting them through the MDR transition, accelerating innovation, and ensuring patient safety. We are proud to be a trusted partner in helping manufacturers bring safe, effective, and compliant medical devices to market worldwide.