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 […]
On 26 May, 2020, the Medical Device Regulation (MDR) will replace the MDD. How will this new Regulation impact Legal Manufacturers? Find out more about all challenges and about how the choice of the right electronic contract manufacturer can help make a difference.
The Medical Device Regulation (MDR) will replace the MDD on 26 May 2020. Medical device legal manufacturers are now in various stages of addressing the many changes implied by the new European Regulation. Main changes are product scope expansion, reclassification of devices, more rigorous clinical evidence, recertification of currently approved devices and the use of […]
We address our warmest congratulations to Lunaphore Technologies SA who ranks #2 among best Swiss startups in the TOP100 Swiss Startup Award!
We are very happy for the team and proud to be part of this great venture with the industrialization and manufacturing of the LabSat™, Lunaphore’s first tumor analysis Equipment.
“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 […]
Cleveland, OH March 2019 – Valtronic, an EMS manufacturer focusing on medical devices, recently invested in two new Juki 3020 SMT pick-and-place machines expanding its SMT lines to meet growth demands. These additions will provide flexibility, depth and breadth to the company’s manufacturing lines.
With the addition of these machines Valtronic now has two complete lines […]
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 […]