3.1. Process Changes / Facility Changes Modifications made to manufacturing processes or production facilities to improve efficiency, adapt to new regulations, or address quality issues. [dsm_advanced_tabs dsm_tabs_bg_color="rgba(255,255,255,0.3)"...
Interactive Guide 3 – 2
3.2. Production Support Providing ongoing technical assistance, troubleshooting, and maintenance to ensure smooth and efficient manufacturing operations, while addressing any issues that arise to maintain consistent product quality and regulatory...
Interactive Guide 3 – 3
3.3. Vendor Management The process for the evaluation, selection and re-evaluation of suppliers providing completed devices, components, materials, accessory devices, and global cloud services to ensure all the products and services meet the...
Interactive Guide 3 – 4
3.4. Design Changes Design/process changes include corrective actions, changes implemented to solve the original issue, changes to turn features on and off for customers, and design documents updated to reflect the changed design. [dsm_advanced_tabs...
Interactive Guide 3 – 5
3.5. Continuous Monitoring Process of data collection, trending, monitoring, and analysis used for design verification and monitoring of medical devices. [dsm_advanced_tabs dsm_tabs_bg_color="rgba(255,255,255,0.3)" dsm_tabs_text_color="#141414"...
Interactive Guide 3 – 6
3.6. QMS Trending Trending for data and performance of Quality Management i.e. trending of audit observations, CAPAs and product issues, etc. [dsm_advanced_tabs dsm_tabs_bg_color="rgba(255,255,255,0.3)" dsm_tabs_text_color="#141414"...
Interactive Guide 3 – 7
3.7. External Assessments Evaluations conducted by independent organizations or regulatory bodies to verify that the manufacturing processes, quality systems, and product outputs meet established standards and regulatory requirements, ensuring continued compliance and...
Interactive Guide 3 – 8
3.8. Product Maintenance Overarching process that can include updates and changes, servicing, technical support, etc. [dsm_advanced_tabs dsm_tabs_bg_color="rgba(255,255,255,0.3)" dsm_tabs_text_color="#141414" dsm_tabs_active_text_color="#141414" module_id="page"...
Interactive Guide 3 – 9
3.9. Post-Market Surveillance Process that defines the requirements for the Post-Market Surveillance (PMS) review and evaluation of the medical device’s continued safety and performance to assure that all post-market surveillance-related information is effectively...
Interactive Guide 3 – 910
3.10. Marketing/Promotional Materials Processes and Review Process for the creation, review and approval of the medical device Promotional/Marketing materials including text and format of the materials (i.e. website, social media posts, brochures, etc.) to ensure...