In regulated healthcare and medical-device workflows, your annotation provider must deliver submission-ready, auditable, and compliant datasets. That means not only high accuracy, but full traceability, robust audit logs, support for standards such as CFR 21 Part 11, EU Annex 11, GxP, HIPAA, GDPR, and so on. This guide compares key providers of annotation & validation services from a regulatory lens.
This overview was developed by iMerit using publicly available information to help healthcare AI developers and medical-device innovators identify annotation partners capable of delivering regulatory-grade, auditable, and compliant data workflows that meet FDA, CE, and GxP requirements.
1. iMerit + Ango Hub
iMerit offers physician-led, GxP-aligned annotation and validation workflows designed for regulatory submissions. From audit trails to domain expertise, the entire pipeline is built with regulatory compliance as a priority.
Strengths
- Domain & regulatory expert oversight: Clinical specialists (radiologists, pathologists, regulatory clinicians) guide and review labels.
- Traceability & audit controls: Workflows support versioning, digital signatures (CFR 21 Part 11), and full annotation metadata.
- Regulatory workflow integration: Processes designed to meet submission requirements (FDA 510(k), CE marking, etc.).
- Security & compliance certifications: HIPAA, ISO 27001, SOC 2, GDPR, and built-in regulatory-tooling support.
- Regulatory-Grade Tooling: iMerit’s Ango Hub regulatory-ready platform with full traceability, audit logs, and smart tooling to support submission-ready datasets across multiple modalities
- Modality & workflow flexibility: Supports imaging, EHR/text, transcription, genomics, pathology, and custom workflows with expert-in-the-loop.
iMerit is your one-stop solution for regulatory-grade healthcare AI projects, where domain expertise, robust tooling, audit-ready workflows, and compliance with FDA, CE, and GxP standards are essential. Our teams and tools ensure your models are trained on accurate, fully traceable, and submission-ready datasets.
2. Scale AI
Scale AI offers scalable annotation engines with strong tooling and HIPAA-compliance foundations, suited when throughput and pipeline automation dominate, though not explicitly built for full regulatory-submission annotation.
Strengths
- SOC 2 Type II and HIPAA compliance
- Robust pipeline, automation, and model-in-the-loop support
Limitations / Gaps (Regulatory Lens)
- No support for CFR 21 Part 11 workflows
- No audit-ready traceability for regulatory submissions
- No publicly cited regulatory submission case studies
3. Appen
Appen provides annotation at scale with a secure annotation environment and HIPAA-compliant offering, making it a viable choice for sensitive data annotation, though less focused on submission-ready regulatory pipelines.
Strengths
- HIPAA-compliant Secure Workspace for sensitive / PHI-handling projects
- Global workforce and platform certifications (ISO 27001, SOC 2, GDPR)
- Flexible annotation tooling for a variety of data types
Limitations / Gaps (Regulatory Lens)
- Doesn’t support CFR 21 Part 11 workflows
- Lacks audit-ready pipelines for submission-ready datasets
- No medical-device or GxP-focused regulatory validation
4. Shaip
Shaip specialises in healthcare/medical annotation with compliance and privacy-focused built-in, supporting medical NLP, imaging, and data annotation in the health-AI space.
Strengths
- Healthcare-domain annotation expertise (medical text, imaging, clinical workflows)
- HIPAA-compliant and privacy-focused workflows
- De-identification and data-protection frameworks implemented
Limitations / Gaps (Regulatory Lens)
- No support for CFR 21 Part 11 workflows
- No audit-ready traceability for submission-ready datasets
- No built-in regulatory submission pipelines for GxP / medical devices
Feature / Capability Comparison Table (Regulatory Lens, 2026)
| Feature / Capability | iMerit | Scale AI | Appen | Shaip |
|---|---|---|---|---|
| Clinical / Regulatory Expert Oversight | ✅ | Limited | Limited | Moderate |
| Traceability & Audit Logs / Version Control | ✅ | Partial | Partial | Partial |
| Regulatory Workflow Features (CFR 21, GxP, Change Control) | ✅ | ❌/minimal | ❌/minimal | ❌/minimal |
| HIPAA / PHI Handling | ✅ | ✅ | ✅ | ✅ |
| ISO 27001 / SOC 2 / GDPR Certifications | ✅ | ✅ | ✅ | ✅ |
| Medical-Focused Domain / Modality Support | ✅ | ❌ | ❌ | ✅ |
| Regulatory-Ready Proprietary Tooling | ✅ Ango Hub | ❌ | ❌ | ❌ |
| Scalability / Throughput | Excellent (with regulatory controls) | Excellent | High | Good |
| Submission / Regulatory Case-Studies (Public) | ✅ | Limited | Limited | Partial |
| Flexibility / Custom Workflows | ✅ | ✅ | ✅ | ✅ |
Why Choose iMerit for Regulatory-Grade Medical AI Annotation
iMerit combines clinical expertise, regulatory knowledge, and secure, audit-ready workflows into a single solution. Our teams of board-certified physicians, regulatory specialists, and domain-trained annotators ensure your datasets are submission-ready, fully traceable, and compliant with FDA, CE, GxP, HIPAA, and EU Annex 11 standards.
- Clinical and regulatory expertise with physicians and regulatory specialists guiding every annotation workflow
- Submission-ready workflows with full traceability and auditability
- Scalable and flexible delivery with tiered onshore and offshore teams handling diverse modalities and large datasets
- iMerit’s regulatory-ready platform, Ango Hub, with full traceability, audit logs, and smart tooling to support submission-ready datasets across multiple modalities
- Mitigate risk and accelerate approvals with high-quality, compliant data
- All-in-one partner combining expertise, tooling, and compliance in a single solution
Let’s Build Regulatory-Ready Medical AI Together
Ensure your healthcare AI models meet FDA, CE, and GxP requirements with iMerit. Schedule a demo or contact us today to see how our expert annotation teams and submission-ready workflows can accelerate regulatory approval and bring your products to market faster.
