Medical device quality assurance ensures compliance, safety, and certification for market entry.
What is ISO 13485?
ISO 13485 defines the requirements for a comprehensive quality management system for the design and manufacture of medical devices. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose. An ISO 13485 certification enables an organization to do business in this highly regulated sector. ISO 13485 is relevant to all manufacturers of medical devices inclusive of subcontract manufacturers.
HELPS YOU IN ACHIEVING:
Compliance with regulatory and customer requirements, product safety, and greater market opportunities, improve your company’s credibility, image, and performance.
What are the key benefits of ISO 13485:2016?
- The promotion and awareness of regulatory requirements as a management responsibility
- Implementation of controls to ensure product safety
- Risk management and design control during product development
- Inspection and traceability for implantable devices
- Documentation and validation of processes for sterile medical devices
- Verification of the effectiveness of corrective and preventive actions
- Improves customer satisfaction
- Compliance with basic quality system requirements with enhancements
- Risk management approach to product development and product realization
- Validation of processes
- Tracking and record keeping
- Certification to this standard enables global trade
- Regular assessments help monitor and improve management systems and processes
- Increases financial performance
WHY SHOULD MY ORGANIZATION IMPLEMENT ISO 13485:2016?
Certification to ISO 13485 is often a mandatory requirement in the highly regulated medical devices industry. This certification demonstrates a quality commitment to regulators and customers regardless of whether organizations engage in global operations or expand locally for new business ventures. The regular assessment process ensures that processes are continually checked for effectiveness and avoids noncompliance issues with regulatory bodies ensuring product safety.
