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Key considerations and tips for submitting good submission files to regulatory authorities

New entry at Asphalion’s MedTech Blog | Key considerations and tips for submitting good submission files to regulatory authorities

Asphalion expert Adi Ickowicz explores key considerations and provides valuable tips for preparing and organizing submission files to ensure a smooth and successful regulatory approval process for your medical device.

Asphalion expert Adi Ickowicz explores key considerations and provides valuable tips for preparing and organizing submission files to ensure a smooth and successful regulatory approval process for your medical device.
September 27, 2023

Asphalion expert Adi Ickowicz explores key considerations and provides valuable tips for preparing and organizing submission files to ensure a smooth and successful regulatory approval process for your medical device.

In the highly regulated field of medical devices, obtaining regulatory approval is a critical step toward bringing a product to market. The submission files that are prepared and submitted to regulatory authorities play a pivotal role in this process.

Have a look at the new entry here: MEDTECH BLOG

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NEWS | Proposed framework for International Recognition of Medical Devices by MHRA

This statement describes the draft policy for recognition by the UK of international regulators’ approvals of medical devices.
This statement and proposed framework applies to medical devices in Great Britain. For guidance on the regulation of devices in Northern Ireland, see Regulation of devices in Northern Ireland.

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