Medical devices not only have to address medical needs but may be required to adapt to major demographic and social changes. In conversation with Mark Semkoff, we reviewed what major trends are impacting the medical device industry. Our society is seeing […]
The COVID-19 pandemic highlighted how devastating unplanned events can be for business continuity. Think about other events such as floods, fire, strikes or political instability that can jeopardize the future of an OEM when manufacturing is stopped for several weeks […]
Changes in market and customer needs, especially during exceptional circumstances like the recent COVID-19 crisis, emphasize the ability for Contract Manufacturers to quickly scale-up the production of a medical device. This requires the right infrastructure, assembly expertise, efficient teams and […]
Medical device manufacturing and marketing in the U.S.A. is regulated by the FDA. Medical device manufacturers must register with the FDA and produce their products with a Quality System that meets the FDA Quality System Regulation and more precisely with the 21 CFR 820. Compliance with regulations is crucial and requires an investment of both […]
Selecting a Contract Manufacturer (CM) is a well thought and time-consuming process. There are many factors that go into making the choice, obvious ones like cost and fit come to the forefront. But one that is often overlooked is the process of onboarding the new project, New Product Introduction (NPI). Transferring all of the knowledge […]
Innovating in medical devices requires knowledge of the medical field and many years of experience. For Albrecht Lepple-Wienhues, Head of New Technologies at Valtronic Switzerland, the question […]
Aleva Neurotherapeutics SA is developing the next generation of implantable Directional Deep Brain Stimulation (DBS) system. These implants help patients with Parkinson’s disease control symptoms such as tremor. Aleva’s Neurotherapeutics directSTIM™ system is unique as its directional stimulation allows the area of the brain to be treated with targeted precision. This will improve therapeutic […]
When customers are sub-contracting the design, industrialization and manufacturing of their medical device to Valtronic, a multi-disciplinary team ensures a seamless process. The success of Valtronic is to a large extent due to […]
Developing products with highest quality standards is essential for medical device manufacturers. Having been certified to both ISO 9001 and ISO 13485 for the past decade, Valtronic and quality manufacturing are long time companions. However, is […]
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