News > Regulatory

10th May 2016

Expert advice from Geldards LLP: The general data protection regulation – how will businesses in the life sciences sector be affected?

The countdown to the General Data Protection Regulation 2016 (“GDPR”) has finally begun! It has now been published in the EU Official Journal and will automatically apply in all member states (without the need for national implementing legislation) from 25th May 2018. It will repeal the Data Protection Directive 1995 (“DPD”) and the national data…

09th May 2016

MHRA approval of Quay Pharma’s GMP manufacturing suites

Pharmaceutical outsourcing specialist Quay Pharma has received full MHRA approval for its newly-installed GMP manufacturing suites at its headquarters in Deeside. The new suites are part of a £3 million investment which has increased the company’s overall manufacturing capacity and enabled it to make larger batches of product in order to continue support through Phase…

14th April 2016

Drumlord: Stronger, Better, Faster, Cheaper

The last few months of 2015 saw MediWales member Drumlord develop its SLA Department through investment in software, productivity improvements and cost restructuring. This has enabled the company to offer its Somos Watershed XC11122 SLA at greatly reduced prices.  Depending on the size and geometry of parts, the company has been able to generate savings of up to 50%…

06th April 2016

THAY Medical gains ISO 13485 and ISO 9001 certification

THAY Medical has recently achieved the first of many steps to becoming a world-class innovator of medical devices in achieving ISO 13485 and ISO 9001 certification. Since incorporating late in 2014, THAY Medical has grown based upon a core competence of human factors engineering focusing on medical devices and drug delivery products. Greg Thay, Managing…

04th December 2015

UK HealthTech reaches new heights

UK HealthTech opened its doors for the fourth time on 1st December at the St David’s Hotel and Spa in Cardiff. The conference was delivered by MediWales and attracted hundreds of professionals, clinicians and industry specialists from around the world. The programme was comprised of two parallel seminar streams; MedTech and BioPharma, and included an essential…

24th July 2015

New bench-top clinical chemistry analyzer launched by EKF Diagnostics at AACC 2015

EKF Diagnostics, the global in vitro diagnostics company, announces the international launch of the Altair™ 240 clinical chemistry analyzer at the American Association for Clinical Chemistry’s (AACC) Annual Meeting and Clinical Lab Expo in Atlanta, Ga, 26-30 July. This new bench-top platform represents EKF Diagnostics’ first fully integrated chemistry system designed for the global market….

14th July 2015

Sharp Packaging Solutions white paper on ‘Product Serialisation to Advance Pharmaceutical Authentication and Patient Safety’

Sharp Packaging Solutions, part of UDG Healthcare plc (LON: UDG), the leading international provider of healthcare services, has launched an informative white paper on the challenges around serialisation titled “Product Serialisation to Advance Pharmaceutical Authentication and Patient Safety”. Counterfeiting and product diversion are major problems faced by the global pharmaceutical industry. In 2007, the World…

01st July 2015

Acuitas Medical receives FDA clearance for fineSA® software

  Acuitas Medical Ltd, a developer of analysis software for magnetic resonance imaging (MRI), has received market clearance from the United States Food and Drug Administration (FDA) for its fineSA software. fineSA is a software package that analyzes MRI data and determines the spacing of structural elements within a region of interest at a resolution…

09th June 2015

International development through innovation and collaboration: Expert Advice from EEN & BIC Innovation

In Life Sciences, finding new partners for collaboration is a key driver for innovation and growth. Looking for a commercial opportunity is a business basic, but how do you find your new markets, new technology or specific R&D? Even in the age of the information superhighway there is no substitute for those hard miles on…

14th May 2015

Magstim Announces FDA (510k) Clearance of rTMS (Repetitive Transcranial Magnetic Stimulation) Therapy System

The Magstim Company Ltd, an innovative and award winning Wales-based medical device manufacturer, has received FDA 510(k) clearance to market its Magstim Rapid2 Therapy System for the treatment of drug resistant Major Depressive Disorder (MDD) in the United States. The clearance enables Magstim to significantly increase access to cutting-edge Repetitive Transcranial Magnetic Stimulation (rTMS) technology…