Iso13485 ppt
- 1. Medical Devices - Quality management system Presentation By: M.Rajashekhara Gowda Process Improvement specialist Veave Technologies
- 2. What is ISO 13485 : 2016 ? Medical devices -- Quality management systems Requirements for regulatory purposes. where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
- 3. Organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities .
- 4. Reason for use ….! While it remains a stand-alone document, ISO 13485 is generally harmonized with ISO 9001. A principal difference, however, is that ISO 9001 requires the organization to demonstrate continual improvement, whereas ISO 13485 requires only that the certified organization demonstrate the quality system is effectively implemented and maintained. Additionally, the ISO 9001 requirements regarding customer satisfaction are absent from the medical device standard.
- 5. Benefits to your Company .. The promotion and awareness of regulatory requirements as a management responsibility Controls in the work environment to ensure product safety Focus on risk management activities and design control activities during product development Specific requirements for inspection and traceability for implantable devices. Specific requirements for documentation and validation of processes for sterile medical devices.
- 6. Certification process Phase 1 • An initial discussion about existing practices to evaluate. Phase 2 • A complete gap analysis of your company with respect to your certification requirement. Phase 3 • A custom written mandatory certification documentation, training and complete pre-assessment. Phase 4 • Certification audit by certification body - guaranteed success !
- 7. Why choose us ? We make Entire process hassle - free for the client. Industry experts. Well documentation. Fast turnaround. Excellent support. Affordable price. Post certification services. Total customer satisfaction.