Medical Devices Demonstrate product safety, quality and compliance. IVD Devices Medical Devices IVD Devices Regulatory Certification PMD Act: Japanese Regulations for Medical Devices 98/79/EC – In Vitro Diagnostic Medical Device Directive – CE Marking for Europe ISO 13485:2016 Standard - Transition, Certification & Auditor Training Medical Device Single Audit Program (MDSAP) Audit & Certification In Vitro Diagnostic Devices Regulation (EU) 2017/746 – CE Marking Certification ISO 9001 – Certification – Quality Management Systems Medical Devices 2003/32/EC - Animal Tissue TSE Species CE Marking 93/42/EEC – Medical Devices Directive, CE Marking for Europe European Medical Devices Regulation: MDR (EU) 2017/745 – CE Marking Certification ISO 13485:2016 Standard - Transition, Certification & Auditor Training Medical Device Single Audit Program (MDSAP) Audit & Certification Regulatory Certification PMD Act: Japanese Regulations for Medical Devices ISO 9001 – Certification – Quality Management Systems
