The requirements for medical devices, including the Medical Device Directive (93/42/EEC), the In-Vitro Diagnostics Directive (98/79/EC) and the Active Implantable Medical Device Directive (90/385/EEC), detail requirements for risk management.
ISO 14971 harmonises global regulations for risk management. This means meeting the requirements of the standard can help you to demonstrate compliance.
Our software helps you manage risks, identify issues and get more data from your management systems.
Confidence you're following best practice
Easy-to-manage speed and cost to get your medical devices to market.
Systematically identify risks
Manage foreseeable hazards, customer complaints and create vigilance reports.
Streamline the regulatory process
Associate documentation, risks, issues and training records in a central system.
Evaluate risk classes
Document likelihood and severity and manage associated issues, workflows and escalation paths.
Assign responsibility and ownership for risks in production, IFU and training.
Integrate with other standards
Associate risks with standards such as ISO 13485 to reduce duplication of effort.
This datasheet explains how medical device companies can use each of Qualsys’s software modules to comply with Standards such as ISO 13485 and ISO 14971.
Learn how Qualsys helps you plan validation, implement an efficient validation process and re-validate when there is a change to your processes and systems.