Medical Device Engineering Services

Moving a product from concept to commercialization quickly and with low risk requires the right tools and experience. At Nortech and its dedicated in-house development house – Devicix – we specialize in product realization for medical devices. Devicix offers you end-to-end product engineering capabilities and top-tier project management to help you beat your deadlines and your budget.

Learn more about Devicix and its services at our sister site, www.devicix.com

At Devicix, our design and engineering services are world-class and ready to meet your dynamic product needs

logo_devicixWith Devicix, you get a vendor that fits your needs. We work alongside your team and provide you with the ability to use our quality system or your own to ensure an efficient approach.

Medical-Grade Design Standards: Devicix is independently certified to ISO 13485 and 14971, and also follows IEC 60601, 62304 and 62366 standards.

World-Class Project Management: your project contact will develop a customized development plan upfront to give your team options for resource allocation and confidence in your timelines.

Engineering Capabilities: few partners can match our ability to offer software, electrical, mechanical and industrial engineering competencies. We also specialize in design transfer so your product reaches the manufacturing floor efficiently.

Geared to Regulatory Requirements: our development process matches up to global regulatory submissions, giving you the ability to consider all markets for your product.

Application Experience
  • Neurological Therapy Systems
  • Cardiovascular Applications
  • Respiratory Applications
  • Orthopedic implants and delivery systems
  • Surgical Tools & Systems
Disciplines
  • Software Engineering
  • Mechanical Engineering
  • Electrical Engineering
  • Industrial Design (including Human Factors)
  • Project Management
  • Quality Management
Certifications & Standards
  • ISO 13485
  • ISO 14971
  • FDA Registered Facilities
  • IEC 60601 (Electronic Medical Devices)
  • IEC 62304 (Medical Device Software)
  • IEC 62366 (Human Factors)
Resources
  • Prototype and product build manufacturing zones
  • Electronic document control systems with remote client access capability
  • Concept Rendering
  • Proprietary mHealth Communications Platform