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 Audit, Interim Management or Trainings - either in Medical Devices, Information 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