Medical Device Industry

From prototype, to product launch, to sustaining engineering, you need a partner that can provide medical device software design and development services that add value to your end product.

You Need a Partner

  • Who can record and implement your requirements
  • With ISO-13485 certified development processes
  • Who can work within your quality management system
  • Who can provide value added services at any stage of your product development
  • Who can assure maximum return on investment for your early stage development efforts

Optimation is your Medical Device Solution Partner

From prototype, to product launch, to sustaining engineering, you need a partner that can provide medical device software design and development services that add value to your end product. Optimation helps bear the burden of industry and project demands to keep you focused on your product. Leveraging our expertise and ISO 13485 certification, we're your partner for medical device applications.

Why Choose Optimation for your Medical Device Development?

We Provide Core Expertise

  • Optimation develops product software on a variety of targets including embedded, mobile, real-time operating systems (RTOS), desktop and web
  • Our product software design and development services are compliant and ready for your 510(K) and PMA submission
  • Optimation produces cGMP compliant and documented process automation and test systems for Class 1, Class II and Class III devices (across product lifecycle)
  • Optimation produces verified product software and validated processes
  • Optimation understands and balances choices between early stage budget limitations, level of concern and early stage design control requirements

We Are Part Of Your Team

Optimation's team of medical device software engineers have been providing these services for over 20 years, and have the knowledge and background needed to meet the stringent requirements pertaining to medical device development. Our engineers can work within your quality system, and if needed, can assist in your quality system development and improvement efforts.

Our Support is Available on Your Terms

Optimation has design and development centers in Houston, Minneapolis, Boston, Philadelphia, Dallas, Denver, Syracuse and Rochester, NY. This means you can have an onshore partner, in your timezone, or nearby.

With support tailored to your needs, Optimation can be there for your team - person to person or via web/teleconferences. You can depend on your project partner, Optimation, to be accessible, and with proven success for over 25 years, you can count on us to be there over your product lifecycle.


Life Sciences and Pharmaceutical Industry

Optimation's work in life sciences spans our 25+ years of experience providing systems integration, controls and instrumentation services.

Quality Processes:

  • ISO 13485
  • ISO 14971
  • IEC 62304
  • IEC 60601-1
  • 21 CFR Part 820
  • 21 CFR Part 11
  • TIR32, TIR36, TIR14969, TIR16142 

''...Optimation satisfied ALL needs ... in a professional manner and executed every aspect of the Software Development Life Cycle for an FDA submission flawlessly. The development team is Class A, in managing multiple efforts, handling changing requirements, and maintaining compliance to a standard that meets or exceeds IEC62304:2006."

Kenny Long, Software Manager - Hospital Ventures, Medtronic MiniMed, Inc., Northridge, CA