About Devicix

shutterstock_3170483Devicix is a medical product realization engineering firm.  We are the engineering and product development services unit for Nortech Systems, Inc. Devicix brings value to medical device OEMs by offering innovative design solutions and comprehensive product development services for Class I, II and III devices for a range of clinical applications. We enable our partners – through our extensive capabilities and expertise – to focus on bringing their new, exciting applications to market quickly and effectively.

Our staff consists of some of the best biomedical, electrical, software, mechanical and industrial design engineers the market has to offer. Together we see more than 100 projects a year across multiple industries within the medical field.

Over the past ten years, we’ve established a record of success across a variety of medical applications, including respiratory, cardiovascular, endoscopic and much more.

When you add up all the services and support we offer to medical OEMs, you see a company aligned with the stringent and unique requirements of our industry.  We excel in supporting devices from concept to commercialization with the regulatory, quality systems, and strong design you need to be successful.

Certifications & Standards

ISO 13485 Certified:  ISO 13485 was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.

ISO 14971 Compliant:  ISO 14791 is a risk management standard for medical devices. It defines a set of risk management requirements. ISO 14971 helps manufacturers to establish a medical device risk management process that they can use to identify hazards, to estimate and evaluate risks, and to implement and monitor the effectiveness of risk control measures.

IEC 60601 Compliant:  IEC 60601 is a family of standards whose scope covers the safety, essential performance and electromagnetic compatibility of Medical Electrical Equipment and Systems. It is technically equivalent to the international standard IEC 60601 and the family comprises over 70 separate standards.

IEC 62304 Compliant:  IEC 62304 defines the life cycle requirements for medical device software. The set of processes, activities, and tasks described in this standard establishes a common framework for medical device software life cycle processes. It is used by US and European medical markets as a benchmark to comply with regulatory requirements.

Benefits for Our Clients

  • Less Client Overhead
  • Less client project management expense on non-core functions
  • Overall risk reduction
  • Easy QMS management
  • Increase efficiency cut costs and continuously monitors performance
  • Stronger support for medical device documentation requirements
  • Ability to support claims testing (regulatory and marketing)
  • Stronger ability to pull in industry best practices and tools