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 General Management
- ISO 13485 Medical Devices
- ISO 14001 Environmental Management
- ISO 27001 Information Security
We also have additional practical experience within these norms and regulations:
- ISO 14971 Risk Management for Medical Devices
- ISO 22301 Business Continuity
- ISO 27017 Information Security for Cloud Products
- ISO 27018 Information Security for personally identifiable information
- ISO 27701 Privacy Information Management
- ISO 31000 Risk Management
- ISO 45001 Occupational health and safety
- ISO 62304: 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
If you have any questions regarding any of these norms, regulations or directives – reach out!