Di Martino Consulting

Medical Devices and Project Engineering

Consultancy Services

Medical Device Approval in EU and MDSAP Countries

Benefit from +10 years of experience at different levels of the medical device industry, from family businesses to global players and authorities, from standard-compliant introduction of electronic QM systems to the implementation of agile methods (e.g. via TIR 45).

Of course, this also includes the creation of technical documentation and the optimization of the QM system to meet the MDR, including auditing services.

Cybersecurity risk management
(e.g. according to IEC 81001-5-1, NIS 2)

The jumble of cybersecurity standards and guidance often leads to unnecessary work and – even worse – to unsuitable cybersecurity with the potential to permanently damage your company's reputation or even get into legal problems.

Get methodological support and get a tailor-made package for your business, based on best practice and experience.

Cybersecurity risk management
(e.g. according to IEC 81001-5-1, NIS 2)

The jumble of cybersecurity standards and guidance often leads to unnecessary work and – even worse – to unsuitable cybersecurity with the potential to permanently damage your company's reputation or even get into legal problems.

Get methodological support and a tailor-made package for your business, based on best practice and experience.

Project Management - Agile / Hybrid / Waterfall

Hands On! Project management, not only in theory but also in practical implementation, especially in contract work, requires stringent project work and a focus on the essentials.

Optimize your projects and receive sound advice and active support in (almost) all functions.