- Regulatory compliance strategy
- Document Control
- The process that enables the determination of all Annex I General Safety and Performance Requirements (GSPRs) applicable to each product and how to handle them,
- Management Responsibility - Responsibilities of the company management in the operation of the company, maintaining quality standards and ensuring its update
- Resource Management - Process of managing resources, including managing subcontractors and suppliers
- Risk Management procedure
- Procedure for performing Clinical Evaluation
- Product Realization and Design Control - Product realization process ranging from product conceptualization to development, production and service delivery
- Procedure to ensure that UDI standards are maintained
- Installing and operating a Post-Market Surveillance (PMS) system and a Post-Market Clinical Follow-Up (PMCF) system for each product
- Procedure for handling communications with competent authorities and Notified Bodies
- Vigilance system procedure
- Measurement Analysis and Improvement - The process of measuring and acting accordingly on data related to product performance and the need for product improvement.
- MDSAP Requirements
- New and up-to-date methods with practical implications for Risk Management
