New subsidiary: pfm medical expert
pfm medical expert provides advice and support on all matters concerning quality management, compliance with MDR requirements and clinical project management.
The European Union Medical Device Regulation (MDR) which governs the medical technology market presents major challenges for companies in this sector. Even though the European Commission has pushed out the timeline for the MDR coming into effect by a year due to the coronavirus pandemic, there is still considerable need for urgent action to face the upcoming challenges. As an independent service provider, pfm medical expert specialises in giving advice on regulatory requirements under the MDR and providing support for clinical project management – for both clinical studies and clinical assessments. In this area, the company also acts as a Contract Research Organisation for medical devices.
pfm medical expert offers an extensive range of services that does justice to the complex issues surrounding medical device legislation. For example, they can oversee the complete transfer of your quality management system from MDD to compliance with MDR, or with DIN EN ISO 13485:2016. They can also generate clinical data, including protocols, biometry, reports and project planning, and carry out clinical assessments and clinical studies for class I to III medical devices, implants, infusion technology and active medical devices. Their central focus is on providing professional advice on all matters pertaining to regulatory affairs, whether for clinical studies or in relation to general regulatory requirements under the MDR. The new company’s portfolio also includes supplying and programming databases, and assisting with the development of technical documentation in compliance with MDR requirements (STED format).
Valuable expertise based on many years of experience
‘We understand the needs of medical technology companies, and we are able to draw on our experience to provide customised support’, explains Katja Klein, CEO of pfm medical expert. Klein goes on to summarise the goal of the new service provider: ‘We aim to serve companies in the medical technology sector who are trying to break into the European market, as well as established companies who still need some support. We work with these companies to develop customised solutions, depending on where exactly their needs lie – ranging from strategy to practical implementation.’
pfm medical expert is a fully-owned subsidiary of pfm medical ag, a medium-sized family company operating on an international scale, with its head office in Cologne. Two other pfm medical subsidiaries, pfm medical titanium gmbh and pfm medical mepro gmbh, are medical device manufacturers and have already completed a successful quality management audit under MDR. All of the valuable knowledge and expertise gained in this process has been brought together in pfm medical expert, and is now being offered to external companies. The interdisciplinary team has been formed from the Regulatory Affairs team at pfm medical ag, and together they represent over 150 years of experience.
Please visit the website for more information and for contact details: www.pfmmedical-expert.de
Short profile pfm medical
pfm medical is one of the leading German providers of special solutions in the healthcare sector. The Cologne-based family-owned company was founded in 1971, and has 600 employees at twelve international locations. In 2019, pfm medical generated an EBIT (earnings before interest and taxes) of EUR 1.7 million with a turnover of EUR 115.5 million.
The medical product provider holds 340 granted property rights in over 90 patent families worldwide and markets a diverse portfolio comprising nearly 3,000 products in over 100 markets.
Its products span the following four medical focus fields: Surgery (e.g. drainage systems and titanised mesh implants), infusion (e.g. mobile electronic infusion pumps and implantable port catheters), histotechnology (e.g. blades and laboratory equipment) and cardiovascular technology (e.g. implantable occlusion devices for the interventional treatment of congenital heart disease and special catheters).
pfm medical combines products and services to a comprehensive package of solutions. For instance, the company provides training and advice to users such as medical practitioners, nursing staff, patients and their families to support optimal therapy outcomes in both inpatient and outpatient healthcare. When developing innovative solutions in close cooperation with leading medical practitioners and specialist partners, pfm medical invariably focuses on improving the quality of life of both users and patients.
pfm medical ag
Wankelstraße 60, 50996 Köln
Tel +49 2236 9641-370