Month: January 2017

ATMP related targeted stakeholder consultation

Several weeks ago, the summary of the responses to the consultation on the development of Guidelines for Good Manufacturing Practice for Advanced Therapy Medicinal Products was announced. It has been developed on the basis of the comments received during the consultation as well as input from consultation with the European Medicines Agency and competent authorities in the Member States. The Commission services developed draft Guidelines on Good Manufacturing Practice (“GMP”) specific to ATMPs.
You can read more at European Commission website.

Surowce, biokompatybilność a wyroby medyczne.

Coraz częściej w procesie projektowania wyrobów medycznych lub podczas ponownej oceny zgodności ( zmiana z MDD na …

Drug Device Combination – mała rewolucja ?

Przysłuchując się dzisiejszemu spotkaniu Multi-stakeholder webinar to support implementation of the Medical Devices Regulation …

Medical device file / Dokumentacja wyrobu medycznego – ISO 13485

Medical device file / Dokumentacja wyrobu medycznego wymieniona w punkcie 4.2.3 Normy PN-EN ISO 13485 czasem nazywana przez …