ISO 13485 is an international standard that defines quality management system requirements for manufacturers of medical devices. ISO 13485 contains requirements essential for organizations operating at any tier in the medical devices and pharmaceutical supply chain. The primary objective of the standard is to facilitate harmonized medical device regulatory requirements and as a result, it includes some particular requirements for manufacture, installation and servicing such as added requirements on record-control, sterilization and risk management. Organizations can register to ISO 13485 as a standalone or in conjunction with an ISO 9001 or other registration. An ISO 13485 certification from us demonstrates your organization’s commitment to provide products and related services that consistently meet customer and regulatory requirements applicable to the medical industry.
Implementing ISO 27001 really helps your company in the following way.
Provides a robust framework for assuring product consistency
Creates a competitive advantage
Engages top management involvement
Ensures a consistent and effective approach to business
Reduces risk factors via the use of risk management
ISO 13485 regulatory requirements for manufacturers of medical devices on an international scale.
A number of countries have incorporated ISO 13485 into their regulatory systems. Compliance with ISO 13485 can be used in support of regulatory compliance.
It incorporates many of the quality management principles and delivers the benefits of an ISO 9001 based quality management system.
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