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Medical devices must meet the requirements of the Medical Device Regulations (MDR). Manufacturers must appoint a person resonsible for regulatory compliance to ensure thier medical device adheres to the MDR. This person would also ensure that the technical documentation is generated and up to date and that the company complies with post market surveillance obligations.
Cranage Veritas can act as your person responsible for regulatory compliance as part of the MDR.
For more information on MDR consultants talk to Cranage Veritas
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