Industry News

Acorn Regulatory FDA to Offer Decrease in Medical Device Fees

Industry News Roundup: August

We are looking at five of the biggest stories in the pharmaceutical, medical devices and clinical trials sectors in the… Read more

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A Tightening of Regulations for Phase I Clinical Studies?

The Food and Drug Administration (FDA) has announced that they have launched a safety probe into fatty acid amide hydrolase… Read more

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Acorn Regulatory to Exhibit at Med in Ireland – Dublin, October 29th 2015

Med in Ireland – October 29th 2015, Dublin Convention Centre, Ireland Acorn Regulatory is delighted to attend the Med in… Read more

EU Medical Device Vigilance Reporting - Part 1 - 'The Abridged Guide' - Acorn Regulatory

Medical Device Post-Market Obligations – a European Perspective: Part 1 – Post-Market Surveillance

Under the European IVD and medical device directives, once a Manufacturer has CE marked their device and placed it on… Read more

CE Marking An App

Do You Want To Find Out About CE Marking An App? Find Out More Here

There has been a veritable explosion in the number of mobile apps which act as aids to patients and clinicians… Read more

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New European Medical Device and IVD Regulation – Where is it?

The long anticipated wait for agreement and adoption of the new European Medical Device and IVD Regulations will go on… Read more

In Vitro Diagnostic Medical Device Regulations Acorn Regulatory

Borderline Medical Devices Covered in EU Manual Update

With the rapid development of new software tools and mobile apps in healthcare, questions arising over classification will become increasingly… Read more

Contact us and enjoy a faster, smoother journey through the maze of European Pharmaceutical and Medical Device legislation with us as your expert guide.
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