Practical resources for modern certification teams
Guides, checklists, and expert perspectives on technical assessment, certification workflows, MDR documentation, and responsible AI adoption.
Published resources
- What Is Certification Body Software?
Certification body software connects applications, competence, evidence, review, decisions and records in one controlled certification workflow.
- MDR Annex II and Annex III Technical Documentation Checklist
A structured overview of the documentation areas commonly associated with MDR Annex II and Annex III.
- Certification Body Software vs Audit Management Software
Compare software designed for certification workflows with general-purpose audit tools across assessments, competence management, evidence and reporting.
- Technical Documentation Assessment Process
Follow the technical assessment workflow from document intake and evidence review to findings, human validation and reporting.
- How AI Is Transforming Conformity Assessment
Explore where AI can improve certification workflows and where human judgment, traceability and accountability remain essential.
- Common MDR Documentation Gaps That Delay Technical Assessment
Learn how incomplete, inconsistent or difficult-to-trace documentation can slow technical assessment workflows.
- How to Reduce Technical Assessment Turnaround Time
Practical ways to improve document intake, reviewer allocation, evidence traceability and assessment reporting.
- Human-in-the-Loop AI for Technical Assessment
Understand how AI can support technical reviewers without replacing accountable human assessment and certification decisions.
- Essential Features of Certification Body Software
A practical feature checklist covering workflow configuration, reviewer competence, evidence, findings, reporting and auditability.
- What Certification Leaders Worry About When Adopting AI
Trust, confidentiality, accountability and adoption are central concerns for certification organizations evaluating AI.
- A Buyer's Checklist for Evaluating AI-Assisted Certification Software
A vendor-neutral evaluation framework for Notified Bodies and Certification Bodies assessing AI-assisted review software: traceability, human oversight, data sovereignty, auditability, validation evidence and exit terms.
- Certification Body vs. Notified Body vs. Accreditation Body: What's the Difference?
Clear definitions of certification body, notified body, accreditation body and conformity assessment body, with the legal basis for each and how they relate in the EU conformity assessment system.
- IVDR Technical Documentation Review: What Notified Bodies Check
A section-by-section reference to what Notified Bodies assess in IVDR technical documentation under Annex II and Annex III of Regulation (EU) 2017/746, including analytical performance, clinical evidence, stability and post-market surveillance.