09 · Healthcare & Life Sciences
Medical Devices & MDR
A medical device is not certified once and for all: classification, evidence and documentation must stay aligned throughout its lifecycle, together with the legal issues the device brings with it.
We follow the regulatory pathway with our MedTech advisor; the legal aspects are handled by the Firm.
Our services
The issues we address
Qualification and classification of the device, software included (Regulation (EU) 2017/745, Art. 51 and Annex VIII).
General safety and performance requirements and technical documentation (MDR Annexes I–III).
Clinical evaluation, post-market surveillance and PMCF across the entire lifecycle.
Interplay with the AI Act, the GDPR and cybersecurity for connected and AI-based devices.
The system, in motion
How we work, phase by phase
A continuous cycle, not a one-off intervention. Select a phase to see what it involves.
The pathway
MedTech Regulatory
Qualification and class
We establish whether the product, software included, is a medical device and which class it falls into (Rule 11 for software). If it embeds AI, we also assess whether it is high-risk under Article 6(1) of the AI Act.
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