Consulting for Software as Medical Devices (SaMD)

We offer consulting services for companies that develop or distribute software intended to be used as medical devices (Software as a Medical Device, SaMD).

FTR ADVISOR provides step-by-step guidance: from analyzing software classification requirements to supporting regulatory and market access strategies, all the way to preparing the technical documentation.

• Classification and regulatory strategy: Identification of the software classification and development of a regulatory strategy plan.
• Regulatory support and CE marking: Preparation of technical documentation and support in managing compliance with applicable standards..
• Cybersecurity compliance
• Support in drafting software-specific technical documentation::

• • Software lifecycle
  • Architecture
  • Test and validation protocols

• Clinical and performance evaluation process: Identification of the required clinical evidence and drafting of the Clinical Evaluation Plan and Report.
• Artificial Intelligence in medical devices: Application of Regulation 2024/1689 (AI ACT) in the certification process of medical devices.

Why choose FTR ADVISOR? Because we are expert, multidisciplinary partners who stay up to date with the evolving regulatory landscape of software as medical devices.