31/03/2020
Medical device regulation consultant is dedicated to assist in technical documentation preparation in compliance with EU CE MDR/ EU CE IVDD/IVDR including clinical evaluation writing.
EU announce new medical device regulation:
MDD Class I/ IIa/ IIb/ III should decare in conformance with MDR 2017/745 by May 25, 2020.
IVDD should declare in confirmance with new IVDR 2017/746 by May 25, 2022.
Jens Medical Consulting provides services:
1.Assisting in EU CE medical device regulation (MDR) compliance or EU CE In vitro diagnositc regluation (IVDR)/IVDD compliance.
2.Onsite training in accordance with CE MDR or guidance CENTR 17223:2018.
3.Assisting in U.S. FDA 510K submission.
4.Assisting in medical device Registration according to Taiwan FDA.
5.Assisting in medical device application according to PMDA (Pharmaceuticals and Medical Devices Agency)
6.Assisting MDSAP (Medical Device Single Audit Program) according to Health Canada medical device regulation.
FDA 510K MDR consultant MDR clinical evaluation clinical investigation IVDR consultant representative
