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European Authorized Representative & CE Marking
Obelis European Authorized Representative Center (O.E.A.R.C.) provides CE Marking regulatory compliance consulting to manufacturers worldwide, in accordance with European Directives such as MDD 93/42/EEC, IVD 98/89/EC
, and Low Voltage Devices 73/23/EEC. Our high quality compliance solutions, proven by our ISO 9002 certification, include Commercial, Regulatory, Administrative, and Market Development Services through our Brussels, Belgium headquarters. Our worldwide regulatory solutions are provided through our global and professional One Link One SolutionT Network.
Medical
Device Compliance Services
Strategic Device Compliance Services is a leader in medical
device standards and regulatory compliance training and support.
We offer Regulatory and Compliance
training by experts involved in the creation of standards
and regulations
. We also offer expertise in the design of efficient and
effective design processes and procedures including Risk
Management according to ISO 14971. We also offer support
in upgrading your device to the new
IEC 60601-1: 2005 (Ed. 3)
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