Obelis Scientific Department Officially Launched!

BRUSSELS - Nov. 7, 2016 - PRLog -- On 1^st 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

·         Notified Body Selection (http://obelismedical.net/ce-marking-services-notified-bod...)

·         Notification of Clinical Investigations (http://obelismedical.net/medical-device-directive-clinica...)

·         Technical File (Creation/Review) (http://obelismedical.net/ce-marking-services-technical-file-services-technical-file-compliance/)

·         Identification of Harmonized Standards (http://obelismedical.net/new-list-of-mdd-harmonized-standards-published-by-the-european-commission/)

·         Clinical Evaluation Report (http://obelismedical.net/medical-device-directive-clinical-investigation/)

·         Risk Management Report (http://obelismedical.net/category/ce-marking-services/)

·         Vigilance & Incident Reporting (FSN & FSCA) (http://obelismedical.net/category/ce-marking-services/)

·         Trade Mark Submissions (http://obelismedical.net/ce-marking-services-extra-services-trade-mark-services/)

·         Training & On-site visits (http://obelismedical.net/ce-marking-services-extra-services-on-site-training/)

·         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/).