The Objective

Implementation plan to achieve compliance with the ISO 13485:2016 standard (Medical devices — Quality management systems — Requirements for regulatory purposes).

Primary Focus of the Project:

• Research and determination of the ISO 13485:2016 Compliance Requirements.
• Gap Analysis and determination of where we need to improve or implement new controls.
• Prepare documentation Requirements in ISO 13485

• Research and determination of the ISO 13485:2016 Compliance Requirements.
• Gap Analysis and determination of where we need to improve or implement new controls.
• Prepare documentation Requirements in ISO 13485

• Working closely with the director who is supervising and available for questions. This will also include the occasional project progress meetings. Schedule to be determined.
• We will provide all available information in a timely manner and will be able to hold web conference meetings on a short notice.