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Development

The development of medical devices is a demanding process where it is crucial to consider both design requirements and regulatory guidelines. The design of a product defines how it should function and appear, while regulatory requirements ensure that it complies with legal standards. LM4med supports you as experts at every step of this process, providing comprehensive assistance to ensure that your product ideas are transformed into marketable solutions.

Developing in accordance with the MDR/IVDR or FDA regulations is a challenging task. The journey from the initial idea to the delivery of a functional prototype is long and requires significant resources and expertise. Our years of experience and knowledge in the medical technology sector ensure that you have a reliable partner by your side. We provide tailored solutions to bring your vision from idea to market-ready product.

Our team is with you in all phases of product development. We advise you on regulatory processes, support you in creating specifications and requirements documents, and handle the development of your product – including design, the medical device file, and risk management. Along the way, we conduct the necessary tests and verifications to ensure that your product meets the highest quality standards.

With our modern infrastructure and extensive resources, you can focus on your core business while we drive the entire development process forward for you.

Motivation for special tasks

Our motivation is reflected in our active product management, where we build comprehensive risk management and conduct accompanying tests such as EMC, ESD, and radio frequency testing. We always work according to defined standards and follow EN ISO 13485. LM4med also takes care of manufacturing transfer, production, product maintenance, and lifecycle management. Our holistic approach ensures that your medical device meets the highest quality standards from development to market entry.

With us, you will successfully navigate all stages of development – from the initial concept to successful market launch. As your innovation partner and market launch specialist in medical technology, we ensure that your products not only meet regulatory requirements but also provide real value to your customers.