Design & Risk Management for MedTech industry
Connected design control and risk management built for ISO 13485, ISO 14971, MDR, IVDR
DESIGN CONTROL & RISK MANAGEMENT
A software that manage products, requirements, risks, verification, validation, and documentation in one structured system designed for medical device companies.
Complete traceability across the Product Lifecycle
Effective Design Control requires more than document management. Medical device companies must maintain clear relationships between user needs, intended purpose, product requirements, risks, design outputs, verification activities, validation results, and quality records throughout the entire product lifecycle.
MedQdoc provides a connected platform that supports Design Control and Risk Management in one structured environment. By linking requirements, risks, tests, documents, and quality activities, teams can maintain complete traceability from initial product concept to market release and post-market activities. This reduces manual work, improves visibility across departments, and helps ensure that critical product information remains consistent and accessible.
The platform supports compliance with ISO 13485, ISO 14971, MDR, IVDR, and FDA QMSR requirements by providing a clear audit trail and documented relationships between records. Engineering, Quality Assurance, Regulatory Affairs, and Product Management teams can collaborate within the same system while maintaining control over revisions, approvals, and product documentation.
Whether you are developing a new medical device or maintaining an existing product portfolio, MedQdoc helps establish a scalable Design Control process that improves compliance, strengthens traceability, and supports better decision-making throughout the product lifecycle.
A Design Control platform
Unlike disconnected spreadsheets and standalone documents, MedQdoc connects every part of the product development and compliance process.
Designed for medical device companies, MedQdoc helps teams comply with ISO 13485 and supports traceability across products, requirements, risks, verification, validation, and quality activities.
- Design Input & Output Management – Connect product definitions, user needs, requirements, risk management activities, verification, validation, and quality events in a fully traceable design control process.
- Risk Management – Support ISO 14971-compliant risk management processes throughout the product lifecycle.
Explore how MedQdoc streamlines Design Control, Risk Management, and Product Traceability while supporting MDR, IVDR, ISO 13485, and ISO 14971 compliance.
MedQdoc is used across the medical device industry
