qmsWrapper Unveils Risk-Based, Event-Driven Compliance Update for Medical Device Industry
qmsWrapper announces a major update to its QMS platform for MedTech companies, introducing risk-based event capture, smart automation, and customizable logs. The release enhances compliance with MDR, IVDR, and QMSR while streamlining workflows and increasing traceability.
Toronto, Canada, July 08, 2025 --(PR.com)-- Smarter, faster, and more flexible compliance management with advanced automation features.
qmsWrapper, a leading provider of Quality Management Software for medical device companies, has announced the release of its latest update, redefining how MedTech organizations manage compliance under MDR, IVDR, and the upcoming QMSR regulations.
The update introduces a risk-based event capture system, smart form automation, customizable process logs, and a centralized Hazard Log—all engineered to make quality compliance more scalable, traceable, and efficient. Designed for startups and growing manufacturers alike, the new features offer enterprise-grade automation with exceptional configurability.
“MedTech organizations often struggle with rigid, non-adaptable systems that complicate compliance,” said Timea Torok, Account Liaison at qmsWrapper. “qmsWrapper provides a truly configurable platform with predefined modules and workflows, while allowing users the freedom to tailor processes to their specific needs.”
The latest version expands the platform’s flexibility through the addition of Events, Custom Logs, and Automated Follow-up Actions—all linked to form data and driven by real-time input.
Key Features Include:
Predefined Quality Events
Built-in flows for Change, Deviation, Non-Conformity, and Feedback, each equipped with integrated risk evaluation and automated follow-up.
Hazard Log for ISO 14971 Compliance
A centralized, audit-ready system for managing and tracking risk in line with international standards.
Custom Logs and Event Modules
Organizations can create tailored tracking systems using custom forms to support unique processes within the same QMS environment.
Smart Form Automation
Forms can now trigger tasks, risk assessments, processes, or other forms automatically, based on dynamic field input such as checkbox selection or status changes.
Connected, Prefilled Workflows
Data flows from one form to another seamlessly, reducing manual entry and minimizing human error.
Action-Ready Events
Every recorded event can initiate automated tasks, new forms, or defined processes, ensuring no issue is left unaddressed.
A Unified QMS Ecosystem
qmsWrapper offers a deeply integrated, fully automated suite of modules, including CAPA, Change Management, Deviation Management, Non-Conformity, Training, Document Control, Audit Management, Project Management, QMS Management, Traceability Matrix, Customer Feedback, Supplier Management, Risk Management, Hazard Logs, Custom Logs, Automated SOP flows, and a built-in Conversation Module.
Every element of the system—from workflows to module structures—is fully customizable, offering an unmatched level of flexibility and control for MedTech quality teams.
The updated version is fully compatible with all current installations. Existing users can access the new features immediately without disruption.
To learn more or schedule a demo, visit: https://store.qmswrapper.com/
Media Contact:
Nena Scot
Marketing & Communications
qmsWrapper
contact@qmswrapper.com
qmsWrapper, a leading provider of Quality Management Software for medical device companies, has announced the release of its latest update, redefining how MedTech organizations manage compliance under MDR, IVDR, and the upcoming QMSR regulations.
The update introduces a risk-based event capture system, smart form automation, customizable process logs, and a centralized Hazard Log—all engineered to make quality compliance more scalable, traceable, and efficient. Designed for startups and growing manufacturers alike, the new features offer enterprise-grade automation with exceptional configurability.
“MedTech organizations often struggle with rigid, non-adaptable systems that complicate compliance,” said Timea Torok, Account Liaison at qmsWrapper. “qmsWrapper provides a truly configurable platform with predefined modules and workflows, while allowing users the freedom to tailor processes to their specific needs.”
The latest version expands the platform’s flexibility through the addition of Events, Custom Logs, and Automated Follow-up Actions—all linked to form data and driven by real-time input.
Key Features Include:
Predefined Quality Events
Built-in flows for Change, Deviation, Non-Conformity, and Feedback, each equipped with integrated risk evaluation and automated follow-up.
Hazard Log for ISO 14971 Compliance
A centralized, audit-ready system for managing and tracking risk in line with international standards.
Custom Logs and Event Modules
Organizations can create tailored tracking systems using custom forms to support unique processes within the same QMS environment.
Smart Form Automation
Forms can now trigger tasks, risk assessments, processes, or other forms automatically, based on dynamic field input such as checkbox selection or status changes.
Connected, Prefilled Workflows
Data flows from one form to another seamlessly, reducing manual entry and minimizing human error.
Action-Ready Events
Every recorded event can initiate automated tasks, new forms, or defined processes, ensuring no issue is left unaddressed.
A Unified QMS Ecosystem
qmsWrapper offers a deeply integrated, fully automated suite of modules, including CAPA, Change Management, Deviation Management, Non-Conformity, Training, Document Control, Audit Management, Project Management, QMS Management, Traceability Matrix, Customer Feedback, Supplier Management, Risk Management, Hazard Logs, Custom Logs, Automated SOP flows, and a built-in Conversation Module.
Every element of the system—from workflows to module structures—is fully customizable, offering an unmatched level of flexibility and control for MedTech quality teams.
The updated version is fully compatible with all current installations. Existing users can access the new features immediately without disruption.
To learn more or schedule a demo, visit: https://store.qmswrapper.com/
Media Contact:
Nena Scot
Marketing & Communications
qmsWrapper
contact@qmswrapper.com
Contact
qmsWrapper
Nena Scot
(718) 593-4444
www.qmswrapper.com/
Nena Scot
(718) 593-4444
www.qmswrapper.com/
Contact
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