UKCA product marking - 18/12/2024

New medical device marking requirements and regulations in Great Britain

Since Brexit, additional regulations for medical devices have come into effect in Great Britain, i.e. England, Wales and Scotland. Although the transition periods have been extended, medical device manufacturers should familiarise themselves with the new conformity marking requirements. EU medical device regulations will continue to apply in Northern Ireland.

On May 17, 2024, aesco solutions, a leading group for production and development services (CDMO) for medical device companies, and D11Z. Ventures GmbH & Co. KG (formerly Zukunftsfonds Heilbronn) announce the closing of the acquisition of seleon GmbH.

The German Cancer Society has certified the Center for Personalized Medicine (ZPM) at Heidelberg University Hospital. At the ZPM Heidelberg, patients with advanced and rare cancers and, in future, people with severe chronic inflammatory diseases will receive a molecular genetic analysis. The detailed information can open up new treatment options for those affected.

TÜV SÜD has received approval as a UK Approved Body (UKAB) for medical devices. With this approval, medical device manufacturers can implement UKCA certification for the UK market and CE certification for the European market in a time- and cost-efficient manner with TÜV SÜD.

Article - 14/04/2021

Calling for quality seal for implants

Today's seniors are older and more active, which is why implants remain in the body longer and are subjected to greater strain than before. Improved surfaces are expected to ensure that the implants heal and integrate into the bone optimally. In an interview with BIOPRO, Dietmar Schaffarczyk, CEO of Konstanz-based stimOS GmbH, explains why a voluntary quality seal makes sense and gives consumers a better chance of recognising high-quality…

High-tech - 20/10/2016

Industry 4.0 in the medical technology and pharmaceutical industry sectors

The digitalisation of industry affects the entire value chain. From individual products to digitising workflows in companies and connecting companies with clients and service providers via the Internet of Things – Industry 4.0 makes completely new manufacturing processes possible and requires new and specific business models.

Dossier - 25/03/2013

Biotechnology goes automated

Processes that previously required pipetting analysis and production to be carried out manually are increasingly now controlled by automated systems. However this has not necessarily involved a complete reinvention of the wheel instead automation systems used in the plant construction and mechanical engineering sectors are being adapted and optimised for application in the life sciences.