At PSI we believe two (or more) heads are better than one when developing custom medical software.

The development of any custom medical software system involves technical risks which may manifest into roadblocks that break timelines and blow budgets. PSI can help you identify and mitigate these risks before they endanger your product’s development. This allows you to focus on the science behind your project and be assured that the technical risks have been thought through and are well in hand.

Often, the most abstract and sometimes most difficult to define part of a device is the software. Without thorough analysis and specification, the software thus can become the single critical path, lengthening the project, increasing cost, and causing missed opportunity. PSI works closely with its clients, bringing the stakeholders together to create a clear requirement specification on which solid design can be based.

Custom medical devices, whether of minor, moderate, or major level of concern require adherence to strict design controls for FDA clearance, and more importantly, safe operation. PSI believes that designs must convey necessary detail to managers, engineers, inspectors, and quality assurance personnel to build consensus and provide direction on implementation.

As the health and safety of patients depend upon its operation, medical devices must perform reliably and predictably. PSI’s strict coding standards, well defined processes, and knowledgeable engineers create code that is clear, concise, and maintainable. This provides you savings and peace of mind as your device goes into the field, reliably fulfilling its intended purpose.

Both you and the FDA need assurance that your medical device operates as intended and performs reliably in the field.Medical Software Testing with traceability throughout the entire development process ensures the software’s quality. PSI works with you to create and execute verification and validation suites for your medical device software that are clear, thorough, and repeatable.

Companies often require software-focused third parties to evaluate existing code set or documentation packages to serve a given purpose. Through many years of writing and evaluating software, PSI is exceptional in identifying the capability, scalability, maintainability, extensibility, and quality of software systems. Whether it’s evaluation of software documentation prior to FDA submission or evaluating the potential of an acquired code base, PSI can help.

There are many concerns around software and technologies that require research and consultation. PSI has built its expertise over hundreds of projects and is happy to share this collective experience with you. PSI’s consultants are engineers and understand not only the concepts of creating medical device software, but have the hands on experience to provide concrete recommendations. This can eliminate weeks or months spent on a particular issue or potential dead end. One conversation can save you thousands.