In addition to our Customer Success Department, Obelis has recently introduced a new client-focused Department: Customer Care. Read more here!
CE marking
Obelis partner regulatory training: takeaways from Chemron FDA Korea
An interview with Sarah You about her experience in following one of our expert’s professional trainings on EU Regulations and the insights she gained from it.
New Proposal from the EU Commission for a Cyber Resilience Act
European Commission presented a proposal for a Regulation on cybersecurity requirements for products. Read more!
What are the effects of the implementation of MDR on the EU medical device market?
Discover the effects of the implementation of MDR on the EU medical device market and the most relevant challenges in our new article!
Proposal for a Regulation: focus on renovation and sustainability of construction products
The European Commission published a proposal to revise the CPR in order to address several shortcomings of the current legislation. Find out all the details!
Compliance Success Stories: Meet Samsara Vision!
An interview with Samsara Vision about the different compliance steps and the process to launch their products in the market.
EMC ADCO publishes its market surveillance report on microwave ovens
Alongside ten national market surveillance authorities,62 devices were tested in compliance with the administrative and technical requirements of the EMC Directive 2014/30/EU. Read all the results that the campaign has provided in our article!
Shaping the future of the EU market. The legislative framework for industrial products under revision
In 2008, the European Parliament and the Council jointly adopted the Decision No. 768/2008/EC aiming to set a common framework for a new Industrial Policy. Read more
FAMHP releases its Annual Report: Focus on medical devices
The digital Annual Report 2019 contains interesting figures concerning medicines and medical devices read more about it here.
Medical Device Regulation and Artificial Intelligence: what future requirements?
The Special Committee on Artificial Intelligence in a Digital Age (AIDA), established by the European Parliament, has directed all its efforts in filling current regulatory gaps to develop a European framework on Artificial Intelligence (AIDA, 2021). Read more on the topic here.