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Medical Device Regulatory &. Clinical Experts for new EU Medical Device Regulation. Our Experts guide your teams for a smooth transition...
As of 1 September 2020, all medical devices used by care providers must have a CE marking. Since mid-March, due to shortages caused...
Makrocare labeling teamUpdate and maintenance of core labeling do-ents,Central (HQ) & local compliance.and Management and approval...
Scientific and technological breakthroughs, including sophisticated data collectionand -ytics, have combined to create more...
We support worldwide clients in the evaluation of clinical data do-ented as Clinical Evaluation Reports along with related...
There are several suggestions, recommendations from different health authorities for manufacturers to handle clinical trial aspects...
Global regulatory differences and constant changes to HA submission requirements even in the age of the Common Technical Do-ent...
Currently, only 10-20% of IVDs are subject to Notified Body scrutiny under the IVDD. That number will increase to 80-90% under the...
CMC (Chemistry Manufacturing and Controls) is at the core of most of MakroCare’s Regulatory activities. Over the years, CMC breadth...
ISO TR 24971 is the Technical Report on implementation of ISO 14971 and is not widely known or understood by industry ISO TC 210 and...
It has always been a difficult task to be compliant with the changing regulatory norms. When it comes to labeling, the criticality...
We all aware that the implementation date of Medical Device Regulations (EU) 2017/745 (EU MDR) been extended by one year (26 May 2021)...