Your Partner for Management Systems

As a specialist in management systems and norms we know about the latest trends in these areas from our daily work in  AuditInterim Management or Trainings - either in Medical DevicesInformation Security or Business Continuity.

Currently, the auditors at rameus solutions have these qualifications:

  • ISO 9001:2015 General Management
  • ISO 13485:2016 Medical Devices
  • ISO 14001:2015 Environmental Management
  • ISO 27001:2013 Information Security

We also have additional practical experience within these norms and regulations:

  • ISO 14971:2019 Risk Management for Medical Devices
  • ISO 22301:2019 Business Continuity
  • ISO 27017:2015 Information Security for Cloud Products
  • ISO 27018:2014 Information Security for personally identifiable information
  • ISO 31000:2018 Risk Management
  • ISO 45001:2018 Occupational health and safety
  • ISO 62304:2006/AMD 2015: Software for Medical Devices
  • FDA 21 CFR Part 11: Electronic Signature
  • FDA 21 CFR Part 820: Quality Management for Medical Devices
  • GMP: Good Manufacturing Practices for pharmaceutical and medical device products

Please reach out for specific questions - we are here.