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About ISO 13485:2016

ISO 13485:2016 is an international standard that specifies requirements for a quality management system (QMS) specifically tailored for organizations involved in the design, development, production, installation.

» Scope: ISO 13485 applies to organizations throughout the entire lifecycle of a medical device, from initial development and design to manufacturing, installation, servicing, and disposal.
» Purpose: The primary purpose of ISO 13485 is to help medical device manufacturers and related organizations establish and maintain a quality management system.

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13485-2016 benefits

» Compliance with Regulatory Requirements:

ISO 13485:2016 is aligned with the regulatory requirements of many countries and regions, making it easier for organizations to demonstrate compliance with medical device regulations.

» Global Market Access:

Many countries and markets require medical device manufacturers to have ISO 13485:2016 certification as a condition for market entry.

» Enhanced Product Quality:

ISO 13485 emphasizes quality management and process control, leading to improved product quality and consistency.

» Risk Management:

The standard incorporates risk management principles, helping organizations identify and mitigate risks associated with their products and processes.

Document Required For ISO Certification

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