Built for Design Traceability. Evolving for Full MDR & ISO Compliance.
Over 10% of our customer base develops medical technology, from surgical robotics, IVD analysers, and ophthalmic systems to AI-powered Software as a Medical Device (SaMD). Today, engineering and QARA teams use Requirement Yogi to author technical documentation, structure requirements, and maintain end-to-end traceability matrices.
Now, we are expanding our focus to address the broader regulatory hurdles of MDR (2017/745), ISO 13485, and ISO 14971.
Also: Meet us at the MDR conference in Bern! Reach out to Adrien Ragot in the guest list.
Medical device compliance should not require clunky, million-dollar legacy ALM platforms that engineering teams actively avoid.
What Requirement Yogi solves today:
- Design File: Document product requirements, architecture, and verification/validation directly in your native workspace.
- Granular Traceability: Build bidirectional requirement-to-test links across Jira and Confluence without losing context.
- Audit-Ready baselines: Version, freeze, and export requirement snapshots for notified body review.
Where we are going next:
We know a design dossier is only one piece of the puzzle. True compliance requires seamless risk management (ISO 14971), post-market surveillance integration, gap analysis across standards, structured audit trails, and formal procedure approvals. We refuse to claim we solve full regulatory workflows until we have built and validated the exact tooling QARA teams require.
How MedTech Teams Use Requirement Yogi
Verification & Validation Matrices
Complex electro-mechanical and software systems use structured keys to trace user needs down to component specifications and automated verification tests.
Source: Photo by Vitaly Gariev on Unsplash
Design History File (DHF) Structuring
Technical files organised for notified body readability, maintaining clear relationships between system requirements, software architecture, and risk mitigations.
Source: Photo by Chidera Faustina Okeke on Unsplash
Change Impact & Baseline Freezing
Instant visibility into requirement drift between hardware revisions or firmware releases, simplifying change management documentation under ISO 13485.
Note: Workflows and templates vary by manufacturer. Visualisations reflect common traceability patterns across our medical device user base.
Source: Photo by iMattSmart on Unsplash
Shape our Medical Device roadmap
Are you a Quality Assurance or Regulatory Affairs (QARA) professional navigating MDR technical documentation? We want to build the exact compliance and risk workflows you actually need.
We are conducting brief, 15-to-20-minute research interviews:
- What takes the most manual hours when preparing technical files for notified bodies?
- Where do standard Jira and Confluence setups break down during an audit?
- What does pragmatic risk management (ISO 14971) look like inside your everyday tools?
No sales pitches. No premature feature promises. Just an open discussion on your regulatory bottlenecks.