Cheseaux-sur-Lausanne, Vaud, Switzerland
MyraMedical sarl can support startup companies in executing their product development program towards the CE mark with the following professional supports: 1. Design and prototyping of implantable medical devices especially for transcatheter access. Design, assembling prototypes for preclinical testing; 2. Support for defining Regulatory Preclinical and Clinical strategies to CE mark; 3. Organization and co-ordination of investigational programs in R&D projects for pre-clinical in-vivo and in-vitro testing as well as clinical assessment of safety and efficacy of implantable cardiovascular devices (mechanical, biological and transcatheter heart valves, vascular postheses, bare and drug eluting coronary and peripheral stents); 4. Compilation of technical files for Regulatory submissions to Notify Body for CE mark Specialties: a. Project Management & Business development b. Implantable medical devices design (conventional and transcatheter devices) c. Prototyping of functional devices for first preclinical feasibility tests d. Regulatory development with Notify Bodies e. Assembling of Technical files for CE mark f. Preclinical investigations g. Clinical investigations
MDE supports start‐up companies, research centers and universities during the different stages of development and production of active, non‐active single use medical devices and non‐active implantable devices. MDE can rely on deep internal expertise and competencies enabling to develop innovative devices and making MDE independent from external sources. MDE complies with ISO 13485 and can keep traceability through every stage of prototyping and production up to product packaging and release.
PLYMED was born from the collaboration between two companies, one concentrated in Medical device distribution since 25 years and one focused in Biomedical project development from R&D to CE mark. Each company has developed over the years consolidated knowledge within their own working environment, both with a great desire to expand their professional experience in supplying cutting-edge technologies. PLYMED’s mission is to start a widespread distribution of medical devices and to represent a point of reference in the Swiss healthcare sector, providing the customer with after-sales assistance.
Accountability, Purchase and Logistic management of the company. Manufacturing overview and Technology Transfer Planner to our Joint Venture in China (Shanghai)