Medical Product Software Design

“The close partnership we formed with MPC Data complemented our in-house development team bringing the necessary technical experience on-board together with a strong desire to meet product deadlines.”

Simon Morling, Director of Product Development, Alaris Medical Systems

MPC Data has many years of experience architecting, designing and delivering software for the highly specialised, regulatory controlled, safety-critical medical and healthcare market places, including experience of designing products that would require typically FDA 510k approval, ISO13485 and also IEC60601, the UK/European medical device directive.

By drawing on a substantial software engineering resource, consultants, project managers and engineers, MPC Data can share technologies gleaned from medical and other safety sensitive markets, for example MISRA-C is used in both the automotive and medical sectors.

MPC Data is also familiar with providing the supporting documentation necessary for the application of approvals for software-based products in the medical market place and the processes required to ensure safety aspects of the design are covered.
In order to meet medical project challenges MPC Data’s team keeps up to date with the latest advances in:

Silicon Solutions
Operating Systems, software components and tools
Safety legislation especially relating to systems involving software.
International standards
Emerging technologiesAvailability of open source and COTS components that can reduce cost, timescales and risk.

...and understands:

Which are appropriate for use in the medical field
How to produce risk mitigation strategies, especially where there is no established track record.

...and has systems in place to effectively meet:

The commercial imperatives imposed by cost, risk and competition
Highly demanding project management needs of medical projects

...and can deliver:

To timescale and budget constraints
Requirements, design, risk, and test documentation to the highest standards
Evidence of appropriate testing and adherence to best practices in software development methodologies

A professional software company should be able to exceed the all-round capabilities of the in-house team of all but the largest medical equipment manufacturers. MPC Data’s continuous development of ‘best practise’ approach to the software development process has led to an approved ISO9001:2008 process and we are currently developing software to ISO13485 processes which far exceeds the requirements laid down by most approval bodies.

Contact MPC Data to see how we can help you with your medical product.