Designing and manufacturing of electro-mechanical systems for regulatory compliance.
Conceptualizing, designing, developing, industrializing and manufacturing
Group Quality Management System incorporating standards such as Directive 93/42/EEC, Norm IEC 60601 and 21CFR 820 (FDA regulation)
Vertically integrated industrial design, electronic, mechanical and integrated manufacturing infrastructure
Comprehensive, multi-disciplinary development teams (eg. mechatronics, analog and digital processing, GUI…)
Finished goods Design Master Record (DMR), Design History Record (DHR)
Manufacturing technology transfer
Medical Device Project Management
A team is created with specific competences to fulfill your project requirements with a focus on the following:
Project flow control sustained by Design Review with customer
Customer reporting and product validation
Subcontractor control and monitoring
Interfacing with customers and regulatory bodies
Design History File management
Interested in more detailed Medical Device development capabilities?
Click below to download a presentation on Electronic Medical Device Manufacturing.
Medical Device Prototyping
A dedicated prototyping process combined with strong vendor relationships accelerate time to market for the first functional prototypes. As an ISO13485 certified company, the design and manufacturing processes are integrated in our quality management system, also complying with these standards:
Norm IEC 60601
21CFR 820 (FDA regulation)
Medical Device Production
Customers benefit from our significant experience in medical device industrialization, our teams work:
To apply proven manufacturing processes
To increase the efficiency through Design for Manufacturing (DFM) approach
Irrigation pump for endoscopy with microelectronics and...
Valtronic is a full service global provider of engineering, industrialization and manufacturing for medical devices and related high reliability products from microelectronics and precision machining to complex system integration. Valtronic’s customers are leading global suppliers of medical implants and devices, diagnostic imaging equipment and sensitive aerospace and industrial assemblies. For over 30 years, Valtronic has helped hundreds of companies develop and produce Class II & III medical devices and advanced miniaturized electronic assemblies from our worldwide facilities from Switzerland, the USA and Morocco.