We are managing the entire innovative process to resolve development hurdles within a product lifecycle. We solve complex engineering challenges for medical devices to medical equipment engineering initiatives by working cross-site collaboration in the development processes, and the use of synergies. The control of all interfaces between medical device and drug product development including all necessary design verification and validation activities but also design transfer and process implementation is our key expertise and supports lean and efficient timelines and costs on the way to successful market access in our core regions EU + US.

We believe that better therapy and innovative medical devices as well as eHealth solutions does not necessarily mean higher costs. We guide and execute along a strategic pathway, focusing on product excellence, quality and regulatory compliance with patient-centric solutions that enhance the efficacy, safety and compliance of the treatments, for a controlled overall therapy cost.

We are certified to deal as a Legal Manufacturer together with ISO 13485-certified contract manufacturing partners and can provide full compliance to all lifecycle activities from batch release to post market surveillance as required per MDR 2017/745 within the healthcare market.

We ensure through certification a high level of safety and reliability for compliance with the legal requirements. Our certification confirms the effectiveness of our quality management system for design, development and manufacture of medical devices. We establish our processes in compliance with the current global regulations such as ISO 13485:2016 and MDR 2017/745.

We understand the regulatory and care environment in each respective region. Winning digital solutions cannot be developed as one-size-fits-all solutions. With evolving global regulations, establishing regulatory frameworks is of essential importance to drive successful practices and control strategies throughout the combination product lifecycle, to assure public health. We strive to continuously enhance our regulatory and quality expertise in the pharmaceutical and medical device industry.

We drive all players in the healthcare ecosystem to develop highly patient-centric solutions. We benefit from our global network of developing partners, analytical test houses, raw material suppliers, contract manufacturing partners, consultants and customers, which enables lean and well-organized development strategies and supports arranging new innovative and digital technologies.

We participate in a highly innovative segment to maximize patient outcomes while minimizing healthcare spends. Combination Products leave developing companies with various challenges and commercial risks with the interfaces between medical devices engineering and medicinal product development. As part of the TIEFENBACHER GROUP, we ensure reduced time to market by meeting all regulatory guidances and technical aspects. The skilled R&D and RA personnel significantly de-risk the product in early development, as well as reduce the number of questions from the reviewing agencies.

We contribute to the digital transformation and have the skills, knowledge, and power to tackle all critical issues and leverage the full potential in medical devices and eHealth. Interdisciplinary work is what characterizes us. Exchanging closely and making decisions quickly, we take this advantage to implement innovations very effectively. Our entrepreneurial spirit is a mindset that embraces critical questioning and continuous improvement.