Cesitec advises you on international assessment procedures in medical technology so that your medical devices comply with the relevant guidelines, for example: MDD, MDR, 21 CFR 820 CMDCAS and the respective standards e.g. ISO, IEC, EN or other national or international standards. We advise you or prepare for you the necessary technical documents, which are necessary for a legally safe placing on the market.

Medical technology – quality management

  • Quality management according to ISO 13485:2016
  • Analysis of the right strategy for your quality management system
  • Development of new quality management systems
  • GAP analysis and development of existing quality management systems
  • Integration of further rules into your quality management system e.g. 21 CFR 820 (USA), CMDR (Canada), JGMP (Japan), Korea, Taiwan, China, Russian Federation
  • Qualifications and validations of plants, machines and processes
  • Advice on factory and production planning e.g. Clean rooms, media supply (water, gases), optimal material flows

Medical technology – approval

  • Medical and In Vitro Device Regulation (MDR, IVDR)
  • Creation of technical documentation in international STED format
  • Integration of further rules into your technical documentation, e.g. GMP regulations USA, Japan, Korea, Taiwan, China, CMDR (Canada), GOST-R (Russian Federation)
  • Integration of special standards in your technical documentation e.g. UL, CSA
  • Usability for medical devices according to EN 62366
  • Software as a medical device according to EN 62304
  • Risk management for medical devices according to ISO 14971
  • Clinical evaluations according to MEDDEV 2.7.1
  • Biological evaluations according to ISO 10993