MDR Medical Device Regulations - GMP Advisory Services
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MDR Medical Device Regulations

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Medical Device Regulations

The new Medical Device Regulations (MDR)
were published in 2017 and the clock is now
ticking for manufacturers to meet these
new requirements.

We can help your organization meet
these new requirements.

We take a multistep approach to meeting the new requirements

Review your product portfolio to determine if there are any changes to the classification or the conformity assessment routes

Review your technical files or design dossier against the new Safety and Performance requirements

Identify the gaps

Implement plans and solutions to remediate your technical files/design dossiers.

Successfully obtain a CE mark for the new MDR