Medical Devices Demonstrate product safety, quality and compliance. IVD Devices Medical Devices IVD Devices 98/79/EC – In Vitro Diagnostic Medical Device Directive – CE Marking for Europe Hong Kong, China – Medical Devices Control Office In Vitro Diagnostic Devices Regulation (EU) 2017/746 – CE Marking Certification Transition to ISO 13485:2016 ISO 14001:2015 Revision ISO 22301 – Certification – Business Continuity Management ISO/IEC 27001:2013 – Information Security Management Systems ISO 28000 – Supply Chain Security Management Systems PMD Act: Japanese Regulations for Medical Devices Social Audits Taiwan, China 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 Hong Kong, China – Medical Devices Control Office Transition to ISO 13485:2016 ISO 14001:2015 Revision ISO 22301 – Certification – Business Continuity Management ISO/IEC 27001:2013 – Information Security Management Systems ISO 28000 – Supply Chain Security Management Systems PMD Act: Japanese Regulations for Medical Devices Social Audits Taiwan, China
