Do you need help developing or reviewing technical documentation for the Technical File of your medical device, that comply with MDR and international standards like ISO 13485, ISO 14971, or IEC 62366?
Are you struggling to define your device’s regulatory strategy and build a coherent rationale that integrates usability, risk management, and clinical evaluation into your product development and post-market surveillance plans?
I help with EU MDR technical documentation development and gap assessment, in particular:
‣ Definition and alignment of intended use, product claims, and regulatory strategy
‣ GSPR management and compliance
‣Risk management and analysis (ISO 14971).
‣Usability engineering (IEC 62366): from formative studies to summative validation.
‣Verification & Validation (V&V) planning and documentation.
+Do you need expert support designing clinical trial protocols or analyzing data to validate your product?
+Are you looking for regulatory assistance to update legacy devices and ensure compliance with European authorities?
+Are you preparing for audits/regulatory submissions in Europe or Latin America and need support with your documentation?