The new Clinical Trial Regulation will change the way trials are conducted in Europe and harmonise assessment/supervision processes for European member states.
Technology and innovation
Obelis attends GLAM Consortium Meeting
Obelis Chief Compliance Officer, Mrs. Sandra Ferretti, and Senior Regulatory Expert, Mrs. Louise Olliver, attended…
Obelis Attends Inauguration of CURAM (Center for Research in Medical Devices)
Obelis Chief Compliance Officer, Mrs. Sandra Ferretti, participated in the official inauguration of CURAM – Center for Research in Medical Devices, which took place on Monday, the 26th of September 2016 in Galway, Ireland. The event, co-organised by Dr James J. Browne, the President of NUI Galway and Professor Abhay Pandit, the director of CURAM, brought together world-class academic, medical devices industry and clinical partners.
Obelis Scientific Department Officially Launched!
Obelis officially launched a new scientific department. It aims to aid manufacturers and help spread awareness around obligatory compliance issues.
New Harmonized Standards on R&TTE
EU publishes new harmonized standards for Radio and Telecommunication Terminal Equipment in Europe. Talk to Obelis to find out how they may affect your product.
Obelis Launches the Croatian National Registration Service
Obelis launches new registration and EAR service for non-EU manufacturers seeking to introduce medical and in-vitro diagnostic devices on the Croatian market.
What is the compliance path for EMC & LVD products?
What is the compliance path for EMC & LVD products when trying to bring a wide range of products to the European market? Read on the compliance process here
New Low Voltage Directive 2014/35/EU
From April 2016, low voltage directive 2006/95/EC will be repealed by the new 2014/35/EU LVD.
What are the New Approach Directives?
The New Approach Directives are a series of legislative requirements that ensure product safety within the EU market across a range of products and devices.
The ecological criteria for the award of the EU Ecolabel for rinse-off cosmetic products
More info on required criteria for awarding the Ecolabel to rinse-off cosmetic products within the EU-a voluntary label promoting environmental excellence.