SOP Templates for MDR/ IVDR & international compliance

Modular QMS with international digital health compliance – 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.

Compliance overview
Compliance Overview – In real time

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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 Regulatory Requirements

  1. Regulations: IVDR. MDR, CFRs, MDSAP
  2. 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
  3. ISO/TR 80002-2:2017 Medical device software — Part 2: Validation of software for medical device quality systems
  4. ISO/IEC 20000-1:2018: Information technology — Service management — Part 1: Service management system requirements)
  5. ISO 27005:2018: Information security, cybersecurity and privacy protection — Guidance on managing information security risks
  6. ISO/IEC 27017 Information technology — Security techniques — Code of practice for information security controls based on ISO/IEC 27002 for cloud services
  7. ISO/IEC 27018 Information technology — Security techniques — Code of practice for protection of personally identifiable information (PII) in public clouds acting as PII processors

Digital Health SOP Templates

  • Software Design and Development
  • Best Coding Practices
  • Computer System Validation (FDA, ISO 800002-2, ISO 13485 compliance)
  • Problem Resolution Process (splitted between development and post launch)
  • Software Maintenance and Service
  • Configuration and Change Management
  • Threads Modelling Process 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.