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Iso 13485 is a quality management system standard designed for medical device companies.

Iso medical devices logo.

Design and manufacture of medical devices. Being iso 13485 certification compliant shows a commitment to the safety and quality of your medical devices. Certification to iso 13485. The regulatory approval process for medical devices is complex and not always well defined.

2016 certification the international standard for medical device quality management systems. Cpi today announced that the company has been awarded iso 13485. The fda is the federal agency responsible for the regulatory oversight of medical devices in the u s. Evaluation and testing within a risk management process provides detailed guidance on the assessment of potential biological hazards associated with all types of medical devices including active nonactive implantable and non implantable.

International organization for standardization iso 18562 testing is provided to the fda as part of the 510 k submission. Iso 13485 medical devices quality management systems requirements for regulatory purposes is an international organization for standardization iso standard published for the first time in 1996. This free tool will help you to convert iso 13485 2003 clauses to the new iso 13485 2016 clauses. It represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices this standard supersedes earlier documents such as en 46001 1993.

Establish a risk based approach to product development and realization. Iso 13485 is designed to be used by organizations involved in the design production installation and servicing of medical devices and related services. Cpi awarded iso certification for medical device quality management 30 jan 2020. Iso 13485 2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

Just select the number of your current clause below and you will find out which clause in iso 13485 2016 corresponds with it and what kind of changes do you need to perform in your quality management system for design and manufacture of medical devices to. Iso 13485 2003 vs 2016 conversion tool. It can also be used by internal and external parties such as certification bodies to help them with their auditing processes. For iso 13485 medical devices quality management systems international associates have just had a large extension to scope for accreditation granted by the united kingdom accreditation service ukas that covers category a 1 7 of iaf md 9.