Press Release (ePRNews.com) - BRUSSELS, Belgium - Nov 07, 2016 - On 1st September 2016, Obelis officially launched a new department within the company structure – the Scientific Department. It makes up part of the Compliancy Unit and complements the pre-existing Regulatory Affairs & Quality Assurance Department.
The new department, which has already become fully operational, consists of a group of technical experts (chemists, pharmacists, lawyers) specializing in vigilance & incident reporting, technical documentation (http://obelismedical.net/ce-marking-services-technical-file-services-technical-file-compliance/) and safety analysis (http://obelismedical.net/category/ce-marking-services/). The team is led by Mrs. Sandra FERRETTI – Obelis Chief Compliance Officer.
Scientific Department services include, but are not limited to, the following:
· Borderline Classification (http://obelismedical.net/category/ce-marking-services/)
· Notified Body Selection (http://obelismedical.net/ce-marking-services-notified-bod…)
· Notification of Clinical Investigations
· Technical File (Creation/Review)
· Identification of Harmonized Standards
· Clinical Evaluation Report
· Risk Management Report (http://obelismedical.net/category/ce-marking-services/)
· Vigilance & Incident Reporting (FSN & FSCA)
· Trade Mark Submissions
· Training & On-site visits
· Horizon 2020 (http://obelishorizon2020.net/)
With almost 30 years of regulatory experience, Obelis Group can safeguard your products’ compliance (http://obelismedical.net/medical-device-compliance/) and launch them successfully in the European market. (http://obelismedical.net/eu-market-timeline-harmonization/)
If you need any support in reference to the above-listed services, do not hesitate to contact us (http://obelis.net/contacts/). Source :