Medical Devices Regulations Consultancy
medical devices
About
Medical Devices Regulations Consultancy is a company to provide worldwide regulatory and norm compliance advice, expertise and resources in the medical device consulting industry regarding medium & high risk medical devices throughout the lifecycle of the devices, including both the pre-clinical and clinical phases of development and in both pre-market and post-market period.
Keywords
software iec 62304
labeling
active implantable iso 14708
mdr 2017745
510 estar
regulatory strategy
usability iec 62366
failure mode effect analysis
clinical evaluation mdcg 202013
design history file
basic safety iec 60601
risk assessment iso 14971
clinical investigation iso 14155
sted
due diligence
qms iso 13485
medical equipment manufacturing
medical devices
hospital & health care
Company Information
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Employees 1
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Founded 2023
Location
Pijnacker, South Holland, Netherlands