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For many markets ISO 13485 certification is not sufficient on its own and the appropriate local regulatory certification is also required to legally manufacture and sell medical devices. With a strong reputation for technically correct advice and certification, we have the expert knowledge and global network of auditors to help you achieve your objectives.
For a number of markets ISO 13485 certification is not sufficient on its own and the appropriate local regulatory certification is also required to legally manufacture and sell medical devices. This standard provides guidance for the application of the requirements for quality management systems contained in ISO 13485. This guidance can be used to better understand the requirements of ISO 13485 as it helps illustrate some of the variety of methods and approaches available for meeting the requirements of ISO 13485.
We have been auditing ISO 13485 quality management systems for medical device companies since 2005. Most of our clients are small to mid-size medical device manufacturers. Thus, the 1-2 month timeline below reflects the average amount of time our clients take to achieve ISO 13485 certification. Our ISO 13485:2003 certification ensures your medical device is produced, tried and tested within International standards. ISO 13485 is a Quality Standard governed by the International Organization of Standardization in Geneva, Switzerland, and is recognized and practiced in over 160 countries around the world. CDG™ helps medical device manufactures comply with ISO 13485 by automating, streamlining, and effectively managing the audit process.
Since ISO 13485 is for the medical devices industry, the rules are stringent with respect to the design and manufacture of medical devices and the control of their changes as against maintaining a Environmental Management System (EMS) and its hazards maintenance. ISO 13485 is an enhanced quality management system specifically targeted toward the medical device world. It incorporates a risk management approach to product development and product realization. Process validation is greatly enhanced, which aids to improve the quality of the design and the manufactured product. In addition, product traceability is greatly enhanced in that it is completed to the component level.
ISO 13485 is the quality standard designed for medical device manufacturers. ISO 13485 is also an international standard that is commonly used as the basis of regulatory compliance for the FDA. If you are a medical device manufacturer. The Standard is based on the approach of the general Quality Management System Standard, ISO 9001. It replaces two earlier standards governing medical devices: ISO 13485:1996 and ISO 13488:1996.
This standard does not provide a direct solution to design quality. However it helps to create a framework which enables the use of various solution models depending on the one hand on manufacturer’s size.
The certification of the Company’s compliance with ISO 13485 with CDG recognizes the policies, practices and procedures of our firm to ensure consistent quality in the services and components provided to our customers. Contact CDG today for ISO 13485 Certification of your company.