News > Regulatory

18th April 2018

ABHI Guest Blogs: Andrew Davidson, DTR Medical

In the build-up to the ABHI Seminar: are you ready for Brexit? on 26th April, we asked event speaker Andrew Davidson how his company, DTR Medical, are preparing for Brexit.
28th March 2018

Jellagen Pty Ltd Receives ISO 13485:2016 Certification

Jellagen Pty Ltd is pleased to announce that the Welsh based marine biotechnology company has been certified to ISO 13485:2016 by leading Certification Body – LRQA, for the manufacture of medical grade next generation collagen derived from jellyfish.
08th February 2018

Expert Advice from Abel & Imray: What exactly is protected by a Registered Design?

UK and EU Registered Designs protect the appearance of a product.  The application process is relatively quick, cheap and easy and this has encouraged many companies to obtain this form of IP protection for their products.
16th January 2018

MHRA update to pharmaceutical companies on exit preparations

An update from the Medicines and Healthcare products Regulatory Agency (MHRA) to pharmaceutical companies on preparations for exiting the European Union
25th September 2017

Expert Advice: Clarity Compliance Solutions – Data Integrity

Our top tips when considering Data Integrity
22nd August 2017

Wynne-Jones IP – Why an IP strategy is vital to the pharmaceutical industry

An effective intellectual property (IP) strategy is integral to preserving innovation and continuous progression in the pharmaceutical industry.
23rd March 2017

Expert Advice from Geldards: General Data Protection Regulations – A game changer for everyone

The Information Commissioner has described it as a “game changer for everyone”. So it probably hasn’t escaped your notice that a new, European wide data protection law is on its way. The General Data Protection Regulation 2016 (“GDPR”) will automatically apply in all EU Member States (without the need for national implementing legislation) from 25th…

01st March 2017

Isansys Lifecare Granted Key Patent for Its Innovative Patient Monitoring Platform

Isansys Lifecare, a digital healthcare company developing an innovative patient monitoring platform which enables the early detection of deterioration in patients, today announces that the European Patent Office has accepted for grant a key method patent. The patent relates to the wireless wearable sensor technology incorporated in the Patient Status Engine (PSE), a CE-marked, Class IIa,…

06th February 2017

Alesi Surgical pioneering surgical device gains United States FDA approval

Alesi Surgical Limited, the leading innovator of minimally invasive surgery technologies has successfully secured FDA (Food and Drug Administration) approval for its Ultravision™ system.
13th October 2016

Expert advice from THAY Medical: CE marking usable medical devices

It is now mandatory to show some form of evidence of use safety when CE Marking a medical device. Whether it is a mobile application with a clinical claim, an inhaler or ECG machine - when developing the next iteration or leap in technology or clinic