MedQdoc eQMS
Tailor-Made for MedTech
Validated Cloud-Based eQMS
MedQdoc eQMS is a validated, cloud-based ISO 13485 QMS designed for MedTech companies. It simplifies compliance with MDR, IVDR, and FDA QSR requirements. MedQdoc eQMS - ISO 13485 QMS
MedQdoc eQMS – ISO 13485 QMS for Smarter Quality and Compliance Management
MedQdoc offers a validated, cloud-based eQMS designed for medical device and MedTech companies. Built in compliance with ISO 13485, EU MDR (2017/745), IVDR (2017/746), and FDA QSR (21 CFR Part 820), MedQdoc helps your organization simplify documentation, manage CAPA and quality cases, and stay audit-ready at all times.
MedQdoc is validated and developed by MedQtech, an ISO 13485:2016-certified company. MedQdoc has built-in functionality for companies to comply with MDR, IVDR, QSR, ISO 13485 and ISO 14971 and many more standards
Why Choose MedQdoc eQMS?
- Validated, cloud-based eQMS tailored for medical device and MedTech companies
- Compliant with ISO 13485, ISO 14971, MDR, IVDR, and FDA QSR (21 CFR Part 820)
- Developed by regulatory and quality experts
- Simple implementation, intuitive interface, and rapid time to compliance
- Low total cost of ownership — learn more on our Pricing page
Several MedTech companies have already chosen MedQdoc as their eQMS, achieving outstanding compliance results. Read more in our case study How Inossia Achieved ISO 13485 Certification — and discover a proven, compliant, and cost-effective solution that grows with your organization.
The MedQdoc eQMS – ISO 13485 QMS helps MedTech companies streamline compliance and documentation. MedQdoc eQMS offers a validated, cloud-based solution for medical device companies. The MedQdoc eQMS product simplifies documentation, case management, and compliance with ISO 13485 and MDR requirements.
Document Management
Control, create, and maintain your entire QMS documentation lifecycle in one secure platform. With built-in version control, review and approval workflows, and full traceability, MedQdoc helps you stay compliant with ISO 13485 and QSR requirements while saving time. Easily link processes, templates, and records for seamless collaboration and inspection readiness. Our ISO 13485 QMS MedQdoc eQMS is fully validated for MDR and IVDR compliance.
Learn more about Document ManagementCase Management
Streamline handling of customer complaints, nonconformities, CAPA, and change control. MedQdoc’s Case Management feature enables a transparent and traceable workflow — connecting cases with documents, suppliers, and training records for complete compliance under MDR, IVDR, and ISO 13485. Built for collaboration, visibility, and regulatory confidence. Our ISO 13485 QMS MedQdoc eQMS is fully validated for MDR & IVDR compliance.
Learn more about Case Management
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“I have had the pleasure of performing multiple internal audits on two different companies both using the eQMS MedQdoc. This system is well designed, user-friendly and facilitates not just document control but also effective case management. MedQdoc gives a good overview of the Quality Management System and provides users with the relevant documentation and information as and when required. I wholeheartedly recommend this well-designed system.” Melanie Janbro, Quality Consultant, Vinga Medtech Q Consulting
MedQdoc is used across the medical device industry
