In 2016 two new EU Regulations on Medical Devices were proposed, Regulation (EU) 2017/745, and in-vitro diagnostic Medical Devices, Regulation (EU) 2017/746. Since then, they have been going through the review and approval stages and were formally put into force in May 2017 with parts becoming legally binding in November 2017.
There is a transition period with a staggered application of the regulations, bringing them into full effect in May 2020 for Medical Devices and May 2022 for In-Vitro Medical Devices.
With these dates closing fast, we are here to help with your Stability Storage and Analytical Testing requirements to help gather the data required to meet your obligations in respect of these regulations.
Astoriom have Stability Storage facilities in Tramore (Ireland), Rochdale (England), two in the United States (Atlanta and LA) and Livingston (Scotland) which includes Analytical Testing as well as stability storage.
With multiple walk in rooms, reach in rooms and cabinets offering the ‘standard’ ICH conditions (5°C, 25°C/60%RH, 30°C/65%RH, 30°C/75%RH and 40°C/75%RH) along with minus conditions (-20°C, -40°C, -70°C & -80°C) and bespoke and ‘unusual conditions’, we can meet your expectations and requirements.
Alternatively, we can install and commission, a walk-in room, reach in room or cabinet to meet your requirements at your own site. We would welcome your email, call or visit at any of our facilities.
