Home » Medical Devices Standards Full Framework

Medical Devices Standards Full Framework

Healthcare, ISO 13485, Medical Devices, Quality Management, Quality Management System (QMS), Risk Management

Besides the usual Medical devices global standards and norms:

ISO 13485: Medical devices — Quality management systems — Requirements for regulatory purposes
ISO 14971: Medical devices — Application of risk management to medical devices
IEC 60601: Medical electrical equipment — Part 1: General requirements for basic safety and essential performance

Find bellow an extensive list of applicable standards for most medical devices

(click on any intermediate node to extend the tree. Mouse-over on the standard's name to have its full title. Click on it to visit one of the suppliers)

Note: this tree is partially automatically generated and is intended for a first global approach. Do double-check the requirements and completeness (exemple of mistake: listing the rare earth metals standard for an MRI is not appropriate. An MRI has no real magnet.)

Refer to the standards official organisations listed in our tool directory.

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Topics covered: Medical Devices, Quality Management Systems, Risk Management, Medical Electrical Equipment, Safety Standards, Regulatory Compliance, ISO Standards, IEC Standards, Performance Standards, Clinical Evaluation, Usability Engineering, Biocompatibility, Design Control, Post-Market Surveillance, Validation and Verification, Software as a Medical Device, International Organization for Standardization, and International Electrotechnical Commission..

Avalynn

So, whos going to ensure these medical device standards are constantly updated to match technological advancements? Just curious.

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Alia Greer

Interesting read. However, how does the framework address the integration of AI in medical devices?

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