Clear SOUP and COTS Software for Medical Device Development

The Usual Challenges

Medical device manufactures face the same challenges as everyone building complex systems: time, quality, size (number and complexity of features), and cost. To this we must add functional safety, and pre-market approval by ...

Deterministic and Non-deterministic Systems

In theory, any software system is deterministic; that is, every state and state change in the system can be known, documented and tested. In practice, however, software systems have become so complex that ...

Functional Safety

Malfunctions in medical devices don't usually make the same sort of headlines as airplane or train accidents. For the patient, however, the consequences of an error in a medical device system may be just as dramatic or tragic ...

IEC 62304

IEC 62304 is becoming the de facto global standard for medical device software life cycle processes. The FDA has driven its development, and it is being harmonized with EU standard 93/42 EWG (MDD). Unlike IEC 61508 ...

SOUP and Clear SOUP

Some software vendors make a rather simplistic—and incorrect—distinction between COTS and SOUP. COTS, they say, has a vendor standing behind it, a company that ...

Shopping for COTS Software

At the highest level, the question we must ask of any COTS software we are considering for a medical device is "What proofs does the software vendor provide that his product is what we need?" In addition to ...

COTS Checklist

The following can be used as a high-level checklist to help us determine if a specific COTS component is a good candidate for integration into our medical device software system—essentially, if ...

Conclusion

Neither the IEC 62304 "software for medical devices" standard, nor the demands of functional safety preclude the use of COTS software in medical devices. We must exercise diligence and caution, but COTS ...