Data & Know-How for Life Science

Data & know-how ready to use – plug and play

We believe in a data-driven approach to show traceability from regulation to registration. Data traceability improves compliance know-how for life science products.

In ColabON, consists of connected data and proposals for life science product, which reflects our know-how on the matter.

Regulation Data – Life Science – plug and play

List of standards and regulations
Data for U.S. compliance

Life Science Know-How

Current Harmonised standards for MDR and IVDR compliance. In this page you also find, currently available standard data in colabON. Of course, we licence them properly.

What is a harmonised standard? and why is this important for my company?

Which EN parts of ISO 13485 do I need to apply to conform with MDR and IVDR?

Cyber Security Data

Ready to use in ColabON

  • ISO/IEC 27000:2018 Information security management systems – Overview and vocabulary
  • ISO/IEC 27001:2022: Information security, cybersecurity and privacy protection – Information security management systems – Requirements
  • 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

Check our digital health process templates… because cyber security matters to us

Life Science compliance Data for U.S.

CFR / Title 21 / Parts

  • 11 – Electronic Records; Electronic Signatures
  • 801 – Labeling
  • 803 – Medical Device Reporting
  • 820 – Quality System Regulation
  • 830 – Unique Device Identification

European regulations

  • IVDR 2017/746 In Vitro Diagnostic Medical Devices Regulation – always with current changes
  • MDR 2017/745 Medical Device Regulation – always with current changes

MDSAP Audit Approach MDSAP AU P0002.007

QMS compliance data for Australian, Brazilian, Canadian, Japanese, and U.S. compliance

External Links to standard lists

MDR summary page

FDA List of consensus standards

Standard Data for Life Science

– our selection – ready to use

Here you see all standards that are already in ColabON. We are quite fast in integrating new data. Let us know what you need.

Any further regulations are easy to be made available.