ISO 13485 specifies requirements for a Quality Management System where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such 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 (e.g. technical support). ISO 13485 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.
CERTIFICATION PROCESS FOR ISO 13485
- ISO 13485 Overview & Implementation Training
- Create a Customized Quality Manual
- Process Owner Awareness Training
- Create the QMS Processes & Procedures
- Employee Awareness Training
- Implement & Generate Conformance Records
- Internal Audit & Management Review
- Stage 1 & Stage 2 Registrar Audit
McDae's team is here to make your implementation simple, smooth, and seamless. Our team takes the guesswork out of the certification process and reduces the stress on your internal resources. Our job is to make your job easier and to ensure your ISO 13485 Quality Management System adds value not burden to your company.
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