Iso Medical Devices Logo

Cpi today announced that the company has been awarded iso 13485.

Iso medical devices logo. 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. 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. 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. 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.

Iso 13485 is designed to be used by organizations involved in the design production installation and servicing of medical devices and related services. The fda is the federal agency responsible for the regulatory oversight of medical devices in the u s. The food and drug administration fda issued a final rule use of symbols in labeling june 15 2016 that became effective september 13 2016. It can also be used by internal and external parties such as certification bodies to help them with their auditing processes.

2016 certification the international standard for medical device quality management systems. Iso 13485 2003 vs 2016 conversion tool. 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. Design and manufacture of medical devices.

Iso 10993 1 biological evaluation of medical devices part 1. Cpi awarded iso certification for medical device quality management 30 jan 2020. Certification to iso 13485. Iso 13485 specifies a quality management system that can demonstrate the ability to produce medical devices that consistently meet safety customer and.

The regulatory approval process for medical devices is complex and not always well defined. Establish a risk based approach to product development and realization. Iso 13485 is a quality management system standard designed for medical device companies. Being iso 13485 certification compliant shows a commitment to the safety and quality of your medical devices.