MEGACERT — EU MDR Compliance
MDR Consulting

Our Services

End-to-end medical device regulatory consulting under EU MDR 2017/745.

CE Technical File

Complete technical documentation per MDR Annex II & III.

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Clinical Evaluation

MEDDEV 2.7.1 / MDCG 2020-1 compliant clinical evaluation reports.

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Risk Management

ISO 14971:2019 risk analysis, FMEA, and risk/benefit analysis.

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Biocompatibility

ISO 10993 biological evaluation planning and documentation.

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Validation

IQ/OQ/PQ validation protocols for processes and software.

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Authorized Representative

EU MDR Article 11 authorized representative services.

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Person Responsible for Regulatory Compliance

MDR Article 15 PRRC support for manufacturers.

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ISO 13485 QMS

End-to-end ISO 13485:2016 Quality Management System implementation.

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PMS & PMCF

MDR Article 83-86 post-market surveillance and clinical follow-up.

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IVDR Consulting

In-Vitro Diagnostic Regulation 2017/746 technical files and performance evaluation.

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FDA 510(k)

US FDA premarket notification, US Agent and establishment registration.

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Training Academy

MDR, ISO 13485, ISO 14971, Clinical Evaluation and internal auditor courses.

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