Regulatory submissions to obtain market authorisation to sell a medical device in a specific region is nowadays becoming the bottleneck of the whole market access process.

With the introduction of the EU MDR and IVDR, preparation of technical dossier became more and more complex, with several requirements to be taken in consideration among common specifications, harmonised standards and MDCCG Guidelines.

QualityMedDev provides full support in the preparation or update of the technical dossier for active and non-active medical devices and in-vitro diagnostic devices.

In particular, we can provide support on the following activities:

Preparation or Update of the whole technical dossier

Support on biocompatibility-related documentation: preparation of biological risk assessment, justification in case of failure of biocompatibility tests.

Post-market surveillance documentation (Annex III of EU MDR and IVDR)

Compliance to General Safety and Performance Requirements (Annex I of EU MDR and IVDR)

Risk Management documentation (risk analysis, risk management plan, benefit/risk analysis)

Software Verification and Validation Documentation (IEC 62304, PEMS Validation).

Documentation of Usability Files (ISO 62366)

Labelling preparation according to applicable standards (ISO 15523, ISO 20417) and regulations (eIFU)

Validation of sterilization and packaging

For any information please contact us at info[at]qualitymeddev.com or through the form below.

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