Brussels, Belgium, November 3rd, 2020, Today Obelis and QUNIQUE announced a strategic partnership to exchange expertise and knowledge in the field of the MDR & IVDR, enabling medical device manufacturers to safely transition and become compliant with the new medical device legislation.
Expanded Partnership with Continued Focus on Customer Value Proposition
It became clear that medical device manufacturers are struggling to understand, implement and adapt to the stricter demands imposed by the new regulations. This partnership is formed to offer a more complete support to manufacturers by providing consultancies, tools and technical services towards becoming compliant with the legislation ahead of the required deadlines.
More specifically, Obelis and QUNIQUE are committed to collaborate with regards to classification of devices and borderline devices, gap assessments, and exchange guidelines and expert opinions. Special projects of cooperation include: gap audits and gap assessments, compilation of technical documentation and Person Responsible for Regulatory Compliance.
In addition, Obelis and QUNIQUE will put together a list of trainings, webinars and other educational activities to their respective stakeholders to address regulatory issues and novelties with the objective to raise awareness and provide guidelines on the MDR & IVDR.
Additional Resources
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About Obelis
Obelis is a quality driven, service oriented company based in Brussels, Belgium with over 30 years of experience in regulatory affairs. Obelis operates as one of the largest regulatory centers in Europe today, providing Authorized Representative (EC REP) services. For more information on our mission and services, visit www.obelis.net/services.
About QUNIQUE
QUNIQUEis a skilled service provider in Switzerland serving various stakeholders including but not limited to the medical device and in-vitro diagnostic industry with tailored consultancy services in quality management, regulatory affairs, project management and leadership. For more information about QUNIQUE, visit: www.QUNIQUEgroup.com