Formally confirming that your products and services meet all trusted external and internal standards.
Validating the specifications, value and safety of your raw materials, products and assets.
Evaluating how your products and services meet and exceed quality, safety, sustainability and performance standards.
Quality Assurance in Medical Devices
The medical device industry is governed by complex regulatory systems. Compliance with national and international standards and other requirements is mandatory. Manufacturers of medical devices are responsible for consistently delivering devices that are safe and effective. Certification is needed before entering new markets or prior to customer order placements.
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, greater market opportunities, improves your company’s credibility, image and performance.
What are the key benefits of ISO 13485:2016?
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 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.