Consultants for Medical Device and SaMD Development

Driven by decades of hands-on experience in designing, developing, approving, and maintaining medical devices, apps, and SaMD, we offer expertise in:

• Regulatory Compliance (MDR, IVDR, FDA, ISO 13485, IEC 62304, ISO 14971 etc. *)
• External PRRC, QMS development, and Quality Assurance (QA), including Notified Body inspection and audit readiness
• Design Control, including Systems Engineering, Requirements Engineering, Architectural Design, Verification & Validation, Planning, Execution, and Reporting
• Risk Management including Safety Risk Management (ISO 14971), Cybersecurity Risk Management, and Usability Engineering (IEC 62366-1)
• Project Management of medical device products, including software development management
• Compliance for Artificial Intelligence (AI) and Machine Learning (ML) medical products, including documentation and explainability for Notified Bodies
• Compliance for SaMD, Digital Health, and Connected Medical Device projects
• Internal process audits and supplier audits conducted by certified Lead Auditors

We collaborate closely with trusted partners in Manufacturing, Mechanical Engineering, Analytical Chemical Development, Procurement, and Supplier Management when projects require capabilities beyond our core focus.

* MDR, MDD to MDR, IVDR, FDA, 21 CFR Part 820, ISO 13485, ISO 14971, IEC 82304, IEC 62304, AAMI TIR45, IEC/TR 80002-1, BS/AAMI 34971, ANSI/AAMI SW96, AAMI TIR57, AAMI TIR97, IEC 81001-5-1, IEC 62366-1, IEC 60601-1, IEC 61010-1, ISO TR 80002-2, CMMI, ISO 9000, ISO 9001