Class I and II Electro-Mechanical Medical Devices

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.

 Team Development of Medical Devices
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:
  • Directive 93/42/EEC
  • 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
  • To guarantee a world class quality level

Medical Device Project Flow Control Details

 

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