Date of application of the Medical Device Regulation 2017/745 postponed by one year – use the additional year wisely!
On 3 April, the European Commission adopted a proposal to postpone the application of the Medical Devices Regulation (MDR) by one year. Following adoption by the European Parliament on 17 April, the proposal was adopted by the Council on 22 April with a speeded-up process. The amending Regulation 2020/561 was published in the Official Journal of the European […]
Get to know our leading experts!
We are proud to announce that our Quality Assurance Manager Johanna Nakari has been nominated as Qualified Person (QP). Johanna has vast experience in GMP in the human and veterinary pharmaceutical industry and a proven track record of exemplary performance in various expert roles. During her impressive career of 20 years, she has gained a […]
Are you prepared for the Commission Implementing Regulation (EU) 2018/775 concerning the origin of primary ingredients in food?
New rules have been laid down for indicating the origin of primary ingredient in foods, applicable as of 1 April 2020. The regulation applies to foods containing a reference to the country of origin or the place of provenance in cases in which the origin of the primary ingredient differs from that of the food product. The […]
NEW PRESIDENT AND CEO FOR MEDFILES
The current CEO and President of Medfiles, Tuija Keinonen, has announced her resignation effective as of 30 April 2020. Medfiles announces the appointment of Gregory Ambra as CEO and Norifumi Ninokata as President and CFO of the company, effective 1 May 2020. Mr. Ambra currently serves as the CEO of DZS Clinical Services, Inc., located in New Jersey, […]
Business continuity during the coronavirus pandemic
In order to prepare for the spread of the COVID-19 virus, Medfiles has given its staff precautionary instructions on how to best avoid the COVID-19 infection and to secure uninterrupted service operations according to our business continuity plan and continuous risk assessment measures. Our employees have been instructed to work from home and to organise […]