Clinical Investigations and Studies within medical technologyAs part of the pre-market obligations for medical devices, the clinical approval constitutes a highly cost-intensive and time-consuming process. In-depth clinical evidence on the safety and performance of a medical device as well as its positive risk-benefit ratio must be yielded and presented within the clinical evaluation. Clinical evaluations based on data on similar products that has been published and made publicly available are less and less often acknowledged. The demands made on the quality of clinical data as well as the comparability with one's own medical device have tremendously increased since the MEDDEV 2.7/1 rev. 4 was introduced. In times past clinical studies constituted an exception for the majority of medical devices to be approved, in future they will be required far more often. Also the request for Post Market Clinical Follow Up Studies will increase, addressing indication related technicalities or securing performance demands.
Performing clinical investigations demands a well-established network and detailed knowledge on the actual realisation: Which design and sites of study are best suited for your defined goals? How many study participants are needed? Which endpoints does the clinical study have? These questions will be answered during thorough study planning and preparation. Project management, monitoring, data management and statistics are only a few of the several tasks to be accomplished.
Regulatory Requirements in Medical TechnologyThe continuous changes and amendments made to the rules and regulations for approving medical devices demand highest attention and constant updating of one's knowledge level. For remaining competitive in the market, manufacturers need to be equipped with profound knowledge of all applicable rules and standards and apply them appropriately and traceably.
Medical device approval is complex. The range of services and knowledge built around the topic "Regulatory Affairs" is broad and bears on numerous different directives, laws, regulations and standards. At the same time the internationalisation results in a diversity of country-specific regulations with clear differences.
The core issues of this area are amendments made to products, labelling of the same, and tests prior to market introduction. Establishing and maintaining technical documentation that complies with the Medical Device Regulation (MDR), additional CE Directices, if applicable, and also fulfills the slight differences relevant for international approvals. At this both the requirements of the US Food and Drug Administration (FDA) and the Medical Device Single Audit Programs (MDSAP) occupy a special place.
Product category: Product design, product development
Impossible is nothing
PRODUCT DEVELOPMENT seleon "rock solid medical engineering made in Germany" has a clear objective:
we transform your ideas into products at the pinnacle of medical technology development. Our customers benefit from our many years of industry experience and our comprehensive process and methodology know-how. For housings and carriers, controllers and sensors, valves, mixers, compressors, fans, pumps, software and much more.
You have access to all specialist departments required for the development of complex medical technology systems. The specialised knowledge of our interdisciplinary development team is available to you throughout the entire product development process – from conceptual design to the development of functional models and prototypes to approval and the transfer to series production.
By bundling all process steps for a project, our customers can realise crucial cost advantages while saving time and ultimately obtaining the best possible result for market success
Production As an assembler, all of seleons know-how depends on its employees. All components, test equipment and tools required for assembly are supplied to seleon, where they are assembled into the desired new products.
The synergies of close coordination between development and production are realised in the fabrication of highly specialised devices, produced mainly for the medical technology sector. But since seleon has experience with highly precise technical specifications, we also meet the requirements to serve as a partner in other sectors such as the aerospace industry.
The European authorities and institutions still have to work elaborately on the harmonisation of standards under the Medical Device and In-Vitro-Diagnostics Regulation. Before we try to provide a prospect on further instruments for proof of compliance, we first would like to answer the question of what harmonised standards are and why they are necessary. Also, what recommendations for action apply to manufacturers of medical devices in the current situation, some of which have not yet been clarified.
ONE STOP SHOP seleon gmbh - rock solid medical engineering - made in germany.
seleon is one of the leading engineering and manufacturing providers in the medical device sector with 21 years´ experience. We offer, with our one-stop-shop a wide range of applications complete device development, quality and process management, regulatory & clinical affairs, international product certification support and production transfer.
Our customers - ranging from small and midsize enterprises to large corporate groups - benefit from this expertise.