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The Unique Device Identifier system applies new requirements on all participants under MDR. Read the blog and find out more about UDI’s.

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How To Improve The Readability of Package Leaflets

How To Improve The Readability of Package Leaflets

What changes could be made to the readability of package leaflets to make them more accessible for patients? Eileen Shortiss, a Senior Regulatory Affairs Advisor at Acorn Regulatory is our in-house expert on all matters relating to package information leaflets.  She...

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How To Fix Common eCTD Validation Issues

How To Fix Common eCTD Validation Issues

Previously, we looked at issues that arise within eCTD.  Our Publishing Manager, Eileen Ryan, looks at eCTD validation issues in this article.  The article looks at Module 1 specification issues and more. We have outlined some additional guidance on eCTD validation...

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How To Fix Complications with UUID Numbers in eCTD

How To Fix Complications with UUID Numbers in eCTD

Acorn Regulatory's publishing team is staffed by eCTD experts.  We have assisted many companies in their eCTD projects in recent years.  Many visitors to our website submit questions on regulatory issues. Issues with UUID numbers arise time and again and we are...

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Moving from MDD to MDR? Here Is What You Need To Know

Moving from MDD to MDR? Here Is What You Need To Know

MDR will come into force in 2021.  It differs greatly from the MDD.  What will the major changes be for medical device manufacturers, importers, and distributors? We look at the major changes in the move from MDD to MDR in this article. What is the MDR? Medical...

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How To Write An Effective CER

How To Write An Effective CER

The MDR introduced has new, stricter criteria for CER (Clinical Evaluation Reports), such as the basis of establishing an equivalence with another device

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