ATTENTION: fake certificatesBy Katarzyna Mizerska on 18. December 20180Read more
We were informed about fake MEDCERT certificates. Please note that these certificates were neither issued by MEDCERT nor are...
China: Successful CMEF trade fair in ShenzhenRead more
The 80th China Medical Equipment Fair (Autumn) has taken place from October 29 to November 01, 2018 in Shenzhen,...
EU: European Commission’s Latest Updates to Borderline & Classification ManualRead more
On October 30, 2018 the European Commission published the most updated version of the Borderline & Classification Manual. This...
EU: Guide for the implementation of the MDR and factsheet for manufacturersRead more
The European Commission has published two documents related to the MDR – Medical Device Regulation. The first one is...
Merry Christmas!Read more
Dear customers, business partners and friends! We would like to thank you for another successful year together. We wish...
Survey: medical device companies insufficiently prepared for the new MDRRead more
The survey, conducted by Regulatory Affairs Professional Society (RAPS) and KPMG in June 2018 shows how insufficiently prepared are...
Newsletter May 2018By Katarzyna Mizerska on 16. May 2018Read more
China: successful CMEF and seminar for consulting companiesBy Katarzyna Mizerska on 11. May 2018Read more
The 79th China Medical Equipment Fair (Spring) took place from 11th April to 14th April 2018 in Shanghai, China....
Ukraine: MEDCERT Cooperation with IMPROVE MEDICAL LLCBy Katarzyna Mizerska on 4. May 2018Read more
Ukraine’s new system of conformity assessment and notified bodies for medical devices came into effect on 1 July 2017....
EU: MDCG – The European Commission published its first guidance documents on the MDRBy Katarzyna Mizerska on 4. May 2018Read more
The European Medical Devices Coordination Group (MDCG) has recently published its first guidance documents on the new MDR Medical...
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