What is ISO 13485:2016?
ISO 13485 is the internationally recognized standard for quality management systems in the medical device industry. It is intended for organizations involved in the design, development, production, installation, servicing, and sales of medical devices. Certification demonstrates an organization’s ability to consistently provide medical devices and related services that meet customer and regulatory requirements.
Why is ISO 13485:2016 important?
ISO 13485:2016 is crucial for the medical device manufacturing industry because safety and quality are of paramount importance in this highly regulated sector.
The standard ensures that organizations meet satisfactory standards and comply with legal requirements, guaranteeing that the medical devices they distribute are safe for consumers and effective for their intended purposes.
By establishing detailed guidelines for creating and maintaining a Quality Management System (QMS), ISO 13485:2016 helps organizations systematically address regulatory requirements, enhance product quality, and ensure consistent delivery of safe medical devices.
This not only protects consumers but also builds trust and credibility in the market.
How can CERT-ERN support?
Certification always starts with understanding the standard and implementing a compliant management system. CERT-ERN can provide relevant training, assessments, gap analysis and certification.
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