Medical Device Software
All software development projects need to follow well defined processes to ensure software reliability and efficient project completion. Software included in a medical device whether it be stand alone or a component needs to comply with even more stringent processes with supporting documentation throughout the complete life-cycle.
In Europe the the standards laid down are enshrined in ISO EN62304. Any medical device or in-vitro diagnostics device including software must comply with the tenents of EN62304 if they are to meet the requirements for CE marking in Europe. Equivalent standards apply for devices intended for the US market with respect to FDA approval and GMP compliance.
Ledcourt Associates has detailed experience of implementing suitable processes for medical device software projects. We can assist with
- Creation of SOPs and forms for documenting a compliant process.
- Software Development Life cycle
- Requirements Management.
- Product Change Control & Review
- ISO13485 Quality system compliance