Changes to ISO 9001
At Acorn Regulatory we are committed to ensuring quality in all aspects of what we do so it’s vital to us to stay informed of updates in legislation, requirements or standards in our field of expertise – quality and regulatory....
ISO 9001:2015 – Audit Success for Acorn Regulatory
We are delighted to announce that we have successfully passed our ISO 9001:2015 annual surveillance audit conducted by NSAI on 24th March 2016. NSAI assessed our management system for its compliance with I.S. EN ISO 9001:2015 and found it to be...
QA Specialist & Responsible Person
Acorn Regulatory’s ongoing growth has created an interesting opportunity for a full-time QA Specialist and Responsible Person. The post, which is based in our Clonmel office but allows for remote work, requires a B.Sc. in a Life Science subject and...
Understanding the Changes of MDR in 2021
The advent of the new Medical Devices Regulation (MDR 2017/745) is a cause of much concern for manufacturers and others in the devices sector. The new regulations have brought about many changes compared to the previous regulatory framework. We look...
Most Read Brexit Articles of 2020
Acorn Regulatory has led the way in providing information and assistance to industry professionals since 2016. We have compiled some of the most read and useful articles in one place to help you to better understand how Brexit will impact...
Most Read MDR Articles of 2020
Acorn Regulatory has been at the forefront of the MDR issue. While many economic operators across the industry have been busy preparing for implementation in May 2020, there is some uncertainty at present (March 2020) whether this date will be...
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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. ...
The 3 Options for eCTD Publishing & Submission Services
The transition from paper-based submissions to the more costly eCTD system has caused many companies to reconsider how they undertake regulatory publishing. Acorn Regulatory was an industry leader in the early adoption of eCTD technology in 2014 and we have...
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...
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