The medical device industry is in a state of flux. The new medical device regulation (EU) 2017/ 745 cause major challenges for manufacturers, notified bodies and other economic operators. We work with you to find the easiest and most efficient way to lunch your product globally.

JOOVIS offers a broad level of support:

• EU Medical Device Regulation (MDR) Compliance
• In Vitro Diagnostic Regulation (IVDR) Compliance
• 510K submission
• CE Marking
• Global product registration (SFDA, MFDS, CFDA, Health Canada, ANVISA etc.)
• Full GxP and CAPA remediation strategies and implementation including for FDA 483 & warning letters
• Creating of technical file, design dossier
• Development and creation of Clinical Evaluations Reporting (CER)