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News
04 Dec
MedTech EU issues MDR/IVDR reform statement after EPSCO |
02 Dec
MDCG issues guidance on the publication of medical device clinical trial reports in absence of EUDAMED |
16 Nov
NEW DECLARATION OF HELSINKI – HOW BIG IS THE IMPACT? |
29 Oct
EU Commission updates guidance on borderline medical device and medicinal products |
25 Oct
ISO on the Clinical Evaluation of Medical Devices in progress |
23 Oct
EU PARLIAMENT ADOPTS MOTION TO REVISE MDR |
22 Oct
WMA issues new version of the Declaration of Helsinki |
14 Oct
State of play MDR & IVDR implementation |
09 Oct
CCMO submission portal changes February 2025 |
01 Oct
October is breast cancer awareness month |
19 Sep
A process change for nWMO studies (post-market, non-interventional) per December 2024 |
15 Jul
Draft version of new ISO 14155 published for voting |
10 Jul
EU Commission issues updated timeline for EUDAMED |
25 Jun
MDCG issues guidance on clinical evaluations for orphan devices |
17 Apr
MDCG issues guidance on the investigator’s brochure |
15 Apr
MDCG issues guidance on safety reporting in performance studies under IVDR |
12 Apr
New version of ISO14155 enters enquiry phase with ISO members |
12 Mar
MDCG issues guidance on content and synopsis of the Clinical Investigation Plan for Medical Device studies |
21 Feb
EU Council endorses key updates to the IVDR |
23 Jan
EU Commission proposes IVDR deadline extension |
21 Dec
MDCG issues guidance on exemptions from clinical investigations for class III and implantable devices |
18 Oct
MDCG issues guidance on Medical Device Software (MDSW) – Hardware combinations |
