An Introduction to ISO 13485: 2016 - Quality Management System (QMS) for Medical Devices Training Course (ONLINE EVENT: March 13, 2025) - ResearchAndMarkets.com February 20, 2025 07:10 AM Eastern ...

The FDA has issued its much-anticipated final guidance on cybersecurity risk management in medical devices, effective June ...

Cognidox, a leading provider of electronic Quality Management Systems (eQMS) for medical device and life science companies, today announced the ...

In addition, compliance with international standards, such as ISO 13485 (medical device quality management) and ISO 14971 (medical device risk management), require ongoing updates to security ...

Learn how in vitro diagnostic (IVD) devices can comply with IVDR and Indian MDR standards, ensuring regulatory alignment, ...

Enhance your understanding of medical device Quality Management Systems (QMS) with our regulatory course. , CAPA processes, and root cause analysis t. Tuesday, 02 January 2024 12:17 GMT.

Essential principles are applicable for medical devices and the firm shall adhere with the Quality Management System of Fifth schedule of Medical Devices Rules, 2017.

The US Food and Drug Administration (FDA) has granted 510(k) clearance to PathAI for its digital pathology image management ...

The timing is not coincidental. In 2023, the FDA issued its final guidance entitled "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions." This ...

For instance, the EU’s 2022/2555 Directive on the Security of Network and Information Systems (NIS2) now requires manufacturers of medical products, including chemicals (APIs), pharmaceuticals, and ...