Legacy Software Compliance
We understand the many challenges involved to achieve and maintain compliance with the medical device software IEC-62304 standard, from development tools validation, objective evidence documentation, Quality Management requirements, Risk Management requirements, and the complete post-market lifecycle requirements. When it comes to legacy software, i.e. software that was not developed to the IEC-62304 standard, the regulatory requirements are very specific and manufacturers must ensure their entire QMS is aligned with the IEC-62304 requirements in order to demonstrate rationale for continued use of the legacy software, for its intended use.
Medical Systems Consult are experts in achieving compliance with the IEC-62304 standard for legacy software.
Frequent compliance gaps
- System and software requirements specifications
- Software architecture specification with breakdown of software items and units, and their safety classifications (A, B, or C)
- Traceability between software items, hazardous situations, specific failure causes, risk control measures and verification records
- Software risk analysis aligned with system safety risk analysis
- Post-market information and risk assessment in problem reports investigation
- Rationale for continued use of legacy software for its intended use
Contact a Legacy Software Expert Today:
We have extensive knowledge of FDA and EU regulations for medical device development and product risk management life-cycles. Compliance with FDA QSR, 21 CFR 820.30 design controls, MDD 93/42/EEC, ISO 13485, ISO 14971, EN/IEC 62304, IEC 62366, to support regulatory submissions for market access in the US and International markets. We can review your design history documentation and assist with filling any gaps to prepare a regulatory submission, including predicate research, literature reviewing, safety labeling, and risk management per ISO 14971:2012 international standard.
Contact us today to find out how we can assist with your product development needs.