Medical Device Development

I am able to provide design support services to help your organization advance your product development, product improvement and new product introduction goals. Some of my key areas of focus are:

  • Design Controls

  • Project planning and management including cost and project risk management

  • Requirements definition and management

  • Design inputs and design outputs

  • Software development in agreement with IEC 62304 (Software Life Cycle Processes)

  • Product risk evaluation and management in agreement with ISO 14971 (Risk Management)

  • Design verification and validation including protocol definition, test execution, and generation of verification reports

  • Safety and compliance standards testing including IEC 60601 (Medical Electrical Equipment – Basic Safety and Essential Performance)

  • Product validation and Clinical Evaluation Reports (MEDDEV 2.7/1)

  • Trace matrix definition relationships between product requirements and risk controls, design outputs, and verification and validation results

  • Design transfer to production and continuous improvement

  • Documentation of Design History Files, Technical Files (Technical Documentation), documentation in support of 510(k), CE mark, and other regulatory submissions

  • Considerable knowledge of the expectations and requirements of FDA Title 21 CFR 820 (Quality System Regulation) and Medical Device Directive 93/42/EEC, as well as ISO 13485 (Quality Management System)