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Our regulatory affairs newsletter is filled with industry news, opinion pieces from thought leaders, regulatory affairs jobs and much more. The Acorn Regulatory newsletter is sent on the first Thursday of every month to inboxes all around the world.  It is filled with regulatory, quality and pharmacovigilance articles and whitepapers written by our specialist staff.  They also look at recent projects and create case studies highlighting the issues that they have encountered and the solutions that they have applied. [ninja_form id=8] Each month in the regulatory affairs newsletter we will look at the developments in the pharmaceutical, medical devices, and clinical trials sectors. Right now global events are impacting on these sectors.  Issues such as licensing, the uncertainty caused by Brexit, pricing agreements and much more are causing instability in a sector that relies on certainty.   The newsletter is a perfect digest of what’s happening and will keep you up to date each month. We will also feature articles on industry trends from our team of specialists at Acorn Regulatory.

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Further Reading from Acorn Regulatory

The 5 Responsibilities of the Person Responsible for Regulatory Compliance (PRRC) under MDR

As part of our series of articles looking at some of the changes on the way for medical device regulation under MDR, we are looking at the role of the Person Responsible for Regulatory Compliance (PRRC). The role of QP is a familiar one for those working in the Pharma sector, but this is the first time in European medical devices legislation that a person is required to be appointed by a manufacturer to take specific responsibility for regulatory compliance of devices. Read more here.

Get The 1st Acorn Regulatory Medical Device Regulations Whitepaper

The new medical device regulations (MDR) will come into force in May 2020.  In advance of the deadline, companies across the world are working to ensure that their devices will comply with the new regulations.  For many companies, there is still much work to do. Also, companies are still actively seeking further information about the regulations and how they will be applied. Read the first whitepaper here

2nd Acorn Regulatory MDR Whitepaper

Our second Acorn Regulatory MDR whitepaper looks at the issues of unique device identifiers, the role of Eudamed under MDR, and post-market surveillance. Read the second MDR whitepaper here.

The Medical Device Regulations – MDR – What You Need To Know

The introduction of the new medical device regulations in May 2020 will bring significant changes to the way that we work with medical devices. Our medical device team has been working with many companies to support them for the changeover from the MDD to MDR. During our interactions with these clients, many topics are being raised time and again. Read more here.