You need a Medical Device Solutions Partner Who Can...
Implement your requirements with ISO 13485 certified processes
Work within your quality management system
Provide value added services at any stage of your product development
Assure maximum return on investment for your early stage development efforts
Assist with your manufacturing process validations
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.
Why Choose Optimation for Your Medical Device Development?
We Provide Core Expertise
- We develop 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
- We produce cGMP compliant and documented process automation and test systems for Class 1, Class II and Class III devices (across product lifecycle)
- Our processes are validated and product software are verified
- We understand choices between early stage budget limitations, level of concern and early stage design control requirements
- We assist our client's in identifying the needed software functionality of their medical device and translating those needs into software requirements
- We provide verification and validation solutions to assure our client's requirements are met
- We provide guidance/assistance in the installation, operational and process qualifications of your production process
ISO 13485 Processes
Our processes are ISO 13485 registered, therefore you can be assured that the solutions we provide take into consideration design history and review of potential risks related to the solution provided. Our typical processes and solutions relating to medical device deliverables include:
Our risk review is based on your medical device risk assessment, we identify risks related to our medical device solution, for example:
- What can go wrong
- The likelihood of software/hardware failures and
- Controls to detect and prevent the software/hardware failure or causes
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.