Software validation and Risk Management

Our team of senior SW consultants can assist you to achieve compliance in combination with high productivity in your software development organization.

We offer the following consulting services:

  • Write, review, adjust for software departments
    – Standard Operating Procedures
    – Work Instructions
    – Guidelines and checklists
  • Auditing of software departments
    – QSR and Part-11
    – ISO 14971, IEC 62304, IEC 62366
  • Training
    – QSR and ISO 13485
    – Software risk management, software engineering, agile methods
  • Independent review
    – Product safety strategy
    – Risk Management File
    – Technical File
  • Project manager
    – Product development
    – Compliance improvements
  • Validation of software for regulated processes
    – Administrative software
    – Research and development
    – Manufacturing
    – Maintenance
  • Support during FDA-audits
    – Preparations
    – Back-office support during audits
    – Follow-up activities
  • Iterative methods
    – Agile
    – Lean
    – Integration Centric Development
    – Tool support
  • Application of risk management to information technology (IT) networks incorporating medical devices
    – IEC 80001-1 and the emerging IEC 82304

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