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 […]
“With my medical background and experience in operating rooms, I can identify practical issues when developing a medical device.” – Portrait of Dr. Albrecht Lepple-Wienhues, Head of New Technologies.
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 response […]
“We help our customers improve the design of their medical device for improved manufacturability.” – Portrait of young and talented engineer Jessica Monsman
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 […]
ISO 9001 versus ISO 13485 – What are the differences and which certification is best adapted to medical devices manufacturers?
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 […]
Lunaphore Technologies SA is specialized in cancer research and diagnostic platforms. The company is now launching the LabSat™, its first tumor analysis equipment after several years of research and development. “Considering the machine’s complex assembly and the constraints of IVD (In Vitro Diagnostic) regulation and submission, we have decided to outsource the industrialization and manufacturing […]
The daily life of diabetics is made of regular controls of blood sugar levels and insulin injections. Few diseases require so much attention. With diabetes, daily routines such as working, eating, and exercising take special preparation and involve learning how to plan for these everyday tasks. If the illness is not under control, there is […]
7 Electronic Design Problems that Add Hidden Expense
When developing a product or electronic assembly significant efforts are placed on functionality and on reducing time to market. Often Design for Manufacturing (DFM) takes a back seat without realizing the long-term consequences. Even if the manufacturing cost of a product is within target the manufacturability should be […]
A number of factors such as the rising prevalence of lifestyle and infectious disease, are increasing usage of home-based Point of Care Diagnostics, technological advancements, and decreasing number of technicians in the central labs are driving the growth of the Diagnostics market today. Point of Care (POC) Diagnostics can be broadly defined from infectious disease […]