Management with Executive Responsibility:
- Assures that sufficient personnel are hired with the necessary education, background, training and experience to correctly perform all activities of the Quality System in compliance with the requirements of the company, the CDRH/FDA Quality System Regulation (QSR), Current Good Manufacturing Practice (CGMP), requirements, Title 21 Code of Federal Regulations Part 820 (21 CFR 820), and the ISO 13485 Quality System standards.
- Assures that employees are trained on changes to, or new, standard operating procedures (SOP) and records training.
- Assures that a formal documented review is made of changes to CDRH/FDA cleared medical devices to determine if a new Premarket Notification [510(k)] submission is required.
- Assures that internal audits are conducted to determine compliance with the Quality System requirements and to determine the effectiveness of the Quality System.
- Conducts Management Review at sufficient frequency to determine the suitability and effectiveness of the Quality System and makes changes as necessary.
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