Modular QMS with traces to international standards and regulations – plug and play
Grow your market opportunities with SOP templates for – agile software development – digital health – compliant to MDR and IVDR. These templates are part of ColabON’s modular quality management system. All processes are modeled to interact with each other. Process interaction, inputs and outputs are clearly stated. You can change and release the processes in ColabON without losing traces.
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ColabON’s modular quality system is plug and play – ready to use.
59% faster QMS process release
70% lower QMS maintenance cost
Full traceability between regulatory data (MDR, IVDR, standards) and SOP templates
Digital Health List of applicable standards and regulations
- Regulations: IVDR. MDR, CFRs, MDSAP
- SN EN ISO 13485 and SN EN ISO 14971
- IEC 62304 and IEC 81001-5-1:2021 Health software and health IT systems safety, effectiveness and security — Part 5-1: Security — Activities in the product life cycle
- ISO/TR 80002-2:2017 Medical device software — Part 2: Validation of software for medical device quality systems
- ISO/IEC 20000-1:2018: Information technology — Service management — Part 1: Service management system requirements)
- ISO/IEC 27000:2018: Information technology – Security techniques – Information security management systems – Overview and vocabulary
- ISO/IEC 27001:2022: Information security, cybersecurity and privacy protection – Information security management systems – Requirements
- ISO/IEC 27701:2019 Security techniques — Extension to ISO/IEC 27001 and ISO/IEC 27002 for privacy information management — Requirements and guidelines A new version of the standard is currently in REVIEW
- ISO 27005:2022: Information security, cybersecurity and privacy protection — Guidance on managing information security risks
- ISO/IEC 27017 Information technology — Security techniques — Code of practice for information security controls based on ISO/IEC 27002 for cloud services
- ISO/IEC 27018 Information technology — Security techniques — Code of practice for protection of personally identifiable information (PII) in public clouds acting as PII processors
SOP Templates for agile and cyber-secure product development
- Software Design and Development
- IEC 62304
- ISO 14971
- IEC 81001-5-1
- IVDR/MDR
- Best Coding Practices
- Computer System Validation
- ISO 13485
- ISO 80002-2
- CFR /Title 21/Part 11
- ISO/IEC 27000, 27001, 27005, 27017, 27018
- Problem Resolution Process (splitted between development and post launch)
- Software Maintenance and Service based on ISO/IEC 20000-1
- Configuration and Change Management based on ISO 13485, IEC 62304
- Threads Modelling Process after 27005 and working with risk analysis after ISO 14971
This is how your company can benefit from ColabON:
- More than 5000 regulatory requirements with license rights for 1 year
- More than 400h expert work for interpretation and process descriptions
- More than 200 predefined template contents connected to examples from standards and regulations
- Simplified audit: 100% traceability from requirement to harmonized standards
- 1 day training or audit support
- The data is accessible in ColabON for 1 year
Why ColabON?
Have you read 100 standards? Your engineers like to develop and not read standards. It takes a lot of experience to read and interpret standards. More so, selecting standards is an art. The more you read, the better you understand the similarities and the differences. Also the added value or no-value.
In the last 12 months, several new standards and regulations have emerged that also affect digital health. It’s not just IEC 62304 anymore.