Regulatory Compliance

I provide standards and regulatory compliance support services to help your organization navigate the path to getting your products on the market. Some key areas of focus include:

  • Quality Management System (QMS)

  • Development and improvement of product development, design controls, risk management, customer complaint handling, verification and validation processes

  • Standards conformance to product safety standards such as IEC 60601 (Medical Electrical Equipment – Basic Safety and Essential Performance

  • Compliance with ISO 14971 (Application of risk management to medical devices)

  • Execution of IEC 62366 (Application of usability engineering to medical devices)

  • Regulatory submissions including 510(k) and CE mark

  • Resolution of regulatory issues coming from audit findings and FDA 483s

  • Adverse event reporting and management

  • Construction of Clinical Evaluation Reports (CERs) according to MEDDEV 2.7/1 (Clinical Evaluation)

Compliance.jpg