ISO 13485 Certification
ISO 13485 Certification
ISO 13485:2003 is the international standard that defines quality management system requirements for organizations that design and develop, manufacture, install and service medical devices and design, develop, and provide related services, including manufacturers of materials or component parts that are used in medical devices. The primary objective of the standard is to facilitate harmonized quality management system requirements for regulatory purposes within the medical device sector.
It is derived from the same basic principles as ISO 9001, but places additional emphasis on areas such as documentation, the work environment, risk management, design control and medical device reporting to meet regulatory requirements.
ISO 13485:2003 also provides an effective base model for compliance with:
European Medical Device Directive (MDD) 93/42/EEC
European In-Vitro Diagnostic Directive (IVDD) 98/79/EC
Canadian Medical Device (CMDCAS) Regulations
And requirements of other regulatory bodies located in countries around the world.
System Quality Management for manufacturers of medical devices.
ISO 13485:2003 is an international standard that defines the requirements of quality management system for manufacturers of medical devices.
When medical device manufacturers are active in the global market, the focus on international standards such as ISO 13485, not only gives great advantages, can also be a contractual obligation established by current legislation or customers, therefore, several countries have incorporated ISO 13485 into their regulatory systems, because compliance with this rule may be used to support compliance with current regulations. CDG Provides best ISO 13485 certification services in Delhi India.
What is ISO 13485?
ISO 13485:2003 is an international standard that defines the system requirements for quality management for manufacturers of medical devices. The main purpose of the rule is to facilitate the harmonization of the requirements of quality management system for regulatory purposes in the medical device industry.
It is derived from the same basic principles of ISO 9001. In particular, the requirements for customer satisfaction and continuous improvement have been modified to make them more suitable for regulatory purposes.
ISO 13485:2003 provides a powerful base model for compliance with European directives (MDD - 93/42/EEC, IVDD - 98/79/EC), the Medical Devices Regulations of Canada, and other regulatory requirements located in countries around the world.
Benefits of ISO 13485 Certification:
It is recognized worldwide as the best quality practices between organizations within the medical device industry.
Allows you to work in many countries where it is a statutory requirement and many organizations that applied as a contractual duty or expectation.
Help create a systematic framework in which organizations can monitor, measure and analyze their processes and customer feedback.
Helps provide a framework for implementing the actions (if necessary) to obtain the planned results and to ensure the maintenance of the effectiveness of these same processes with customers, quality and regulatory requirements
can offer better measurable results in key areas of metrics such as increased sales, increased timeliness provide the products to the world market, reduced costs, fewer errors, less waste, better use of time and resources as well and reduce the weaknesses in the product
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