Software as a Medical Device (SaMD) Consultancy Services

Navigating risk management is crucial for SaMD. We provide guidance on:

• ISO 14971 Compliance: Ensuring that your risk management processes align with international standards.
• Usability and Human Factors: Incorporating user-centered design principles to minimize risks associated with software use.

Comprehensive technical documentation is essential for regulatory submissions. We assist with:

• Creating Design History Files (DHF):Compiling all necessary documentation to demonstrate compliance.
• Preparation of Technical Files:Ensuring that your documentation meets the specific requirements of regulatory bodies.

We support you in gathering the necessary clinical evidence to substantiate the safety and efficacy of your SaMD product, including:

• Clinical Evaluation Reports (CER): Developing CERs in compliance with EU MDR and other regulations.
• Real-World Evidence (RWE): Leveraging real-world data to support your claims.

Our team will guide you through the submission process for various markets, including:

• FDA 510(k) and De Novo Requests: Navigating the complexities of the U.S. regulatory landscape.
• CE Marking: Ensuring compliance with EU MDR for SaMD.

We help you establish robust post-market surveillance systems to monitor the performance of your SaMD product, ensuring ongoing compliance and continuous improvement.

We guide you through the entire SDLC, from requirements gathering to testing and validation.

We implement robust quality assurance processes to ensure the reliability and safety of your SaMD.

We help you protect your SaMD from cyber threats by implementing strong security measures.