Iso 13485 Certification

Iso 13485 Certification is a quality standard for organizations that design, develop, produce or service medical devices. It is intended to promote harmonization in the medical device industry and set a basis for quality system regulations world-wide. It includes specific requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate to the medical device industry. All requirements of ISO 13485/134588 are specific to organizations providing medical devices, regardless of the type or size of the organization.

Benefits of ISO 13485 Certification:-
* ISO 13485 promotes harmonization of 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 9001:2000 based quality management system.
* Creates a competitive advantage.
* Ensures a consistent and effective approach to business management.
* Reduces risk factors via the use of risk management techniques.
* Engages top management involvement.
* Provides a robust framework for assuring product consistency.