The ability for Contract Manufacturers to quickly scale-up the production of a medical device is key to help you adapt to changes in market and customer needs. This flexibility in manufacturing is not straightforward for all Contract Manufacturers, at […]
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 […]
Ohio manufacturer Valtronic partners to accelerate delivery to hospitals nationwide
CRESTWOOD, KY, 6th May 2020 –Liberate Medical today announced that it has received Federal Drug Administration (FDA) Emergency Use Authorization for its VentFree™ Respiratory Muscle Stimulator, intended to be used to reduce disuse atrophy of the abdominal wall muscles, which may reduce the number of days […]
Inspire Medical Systems, Inc. is a medical technology company focused on the development and commercialization of an innovative solution for patients with obstructive sleep apnea (OSA). Inspire has developed the first and only FDA-approved neurostimulation device that provides a safe and effective treatment […]
With the COVID 19 pandemic progressing, we are all experiencing an unprecedented situation. Valtronic is of course taking all the necessary measures to safeguard the health of our employees while keeping our focus on another priority, our customers. We would like to inform you that we keep committed to support you during these […]
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.
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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 […]
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 […]
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