News and events of CERES
Keep up with the latest developments of CERES.
New MDR is passed
On 5th April, 2017, the European Parliament passed the final version of the Medical Device Regulation (MDR). Most likely, it will be published until the beginning of June 2017. With the date of publishing, the transition period of three years according to MDR, begins for all manufacturers.
The new rules, specified therein, take into account the technological progress and are intended to drive innovation. Thus, they replace the EU directives 90/385/EEC (AIMDD) and 93/42/EEC (MDD).
For further information CERES will provide you with detailed information.
Chers collègues en France!
We are all very shocked by the assassination in Paris. In great solidarity and deep sorrow, we are connected to our french friends. We will continue to work together with our neighbors for our liberal values that we want to live here every day and continue to live.
Nous sommes tous choqués par les attentats de Paris. Dans une grande solidarité et une profonde tristesse, nous sommes reliés à nos amis français. Nous allons continuer à travailler ensemble avec nos voisins pour nos valeurs libérales que nous voulons vivre ici tous les jours comme vous et continuer à vivre.
Certification of CERES according to EN ISO 13485
CERES GmbH evaluation & research gained ISO 13485 certification.
BSI, the UK’s National Standards Body, certified that we operate a Quality Management System which complies with the requirements of ISO 13485 for the following scope: “Services for managing and performing clinical evaluations for medical devices.” This includes our clinical studies both before and after CE marking, as well as our literature-based clinical evaluations.
We achieved our quality certification on a voluntary basis. This shows that CERES is an innovative and ambitious company, and that quality awareness and customer satisfaction are very important to us. With this certification, we strengthen our clearly-defined control mechanisms for continual optimization. These serve to minimize both cost and risk for our customers through the efficient use of available resources.
Article “High-risk strategies” in Medical Device Developments
Dr. Karen Lunde from CERES published an article in “Medical Device Developments”, November 2014, about the proposed regulations with relevance to medical device manufacturers.
Member of Life Science Alley
As of July, 2014, CERES is now a member of LifeScience Alley.
LifeScience Alley is a global leader in enabling life science business success with a 30-year track record of delivering results-oriented outcomes, committed to leading the conversation in improving our community’s operating environment and supporting advancement in research and healthcare innovation.Here you will find more information about Life Science Alley.
Clinical Operations & Outsourcing in Medical Device Trials conference
On 09.-10. July, 2014 the Clinical Operations & Outsourcing Medical Device Trials conference took place in Minneapolis, Minnesota, USA. CERES participated as an exhbitor and associate sponsor.
We enjoyed meeting people from medical device companies, both large and small. At our booth, we often discussed how we can assist in placing new medical devices on the European market.
Medizin Innovativ – MedTech Pharma
CERES participated as an exhibitor at the MedTech Pharma in Nuremberg on 02.-03. July, 2014.