Software validation

Our team of senior software consultants can assist you in achieving compliance and high productivity in your software development organization.

We offer the following consulting services:

  • *Help software departments write, review and make adjustments
    – Standard operating procedures
    – Work Instructions
    – Guidelines and checklists
  • Software department auditing
    – QSR and Part-11
    – ISO 14971, IEC 62304, IEC 62366-1, IEC 82304-1
  • Training
    – QSR and ISO 13485
    – Software risk management, software engineering, agile methods
  • Independent reviews
    – Product safety strategy
    – SOUP strategy
    – Risk management file
    – Technical File
  • Software quality assurance
    – Static analysis
    – Traceability
    – Software tools
  • Legacy software
    – For medical device companies that have developed and delivered software to the market prior to the publication of IEC 62304, retrospective software validation can be both challenging and time consuming.
    We support companies in making the transition to IEC 62304 compliance, in alignment with regulatory expectations and without unnecessary extra work.
  • Project manager
    – Product development
    – Compliance and productivity improvements
  • Software validation for regulated processes
    – Quality related
    – Research and development
    – Manufacturing
    – Maintenance
  • Application of risk management in information technology (IT) networks incorporating medical devices
    – IEC 80001-1 and the recently published IEC 82304-1

Contact me for further information
Robert Ginsberg
Office +46 8 621 01 05 or send me an mail