AI-Airlock: MHRA’s new way to test and regulate AI in healthcare

AI-Airlock: MHRA’s new way to test and regulate AI in healthcare

AI is transforming the healthcare sector in many ways, from improving diagnosis and treatment to providing personalised care and support.

1.2.2024

CE Mark extension is NOT Automatic

CE Mark extension is NOT Automatic

The EU MDR extension for certain medical devices only allows you up until 31st December 2027 or 2028 if you have a signed contract..

29.1.2024

Understanding Serious Injuries Caused by Medical Devices: What Happens Next?

Understanding Serious Injuries Caused by Medical Devices: What Happens Next?

Prioritise patient safety with these steps!

27.10.2023

Pre-market Submissions for Device Software Functions

Pre-market Submissions for Device Software Functions

MedTech is not just about a medical device with capabilities!

11.8.2023

IVDR Documentation Submission – Best Practices

IVDR Documentation Submission – Best Practices

IVDR Documentation Submission Best Practice Guidelines

4.8.2023

UKCA and CE Mark

UKCA and CE Mark

Are the deadlines extended?

2.8.2023

AI and Cybersecurity for Medical Imaging Diagnosis.

AI and Cybersecurity for Medical Imaging Diagnosis.

Protect your medical solutions from the threats and vulnerabilities of AI!

30.6.2023

Annex III EU MDR

Annex III EU MDR

Your guiding light to navigate regulatory compliance!

18.5.2023

Annex II EU MDR

Annex II EU MDR

All the aspects related to Technical Documentation of a medical device.

15.5.2023

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