Canada, May 22, 2023 - This comprehensive release introduces several key enhancements, including added process templates that are further supporting the Medical Device Regulation (MDR) and strengthened security measures. With these advancements, qmsWrapper is dedicated to helping medical device manufacturers navigate the complexities of changes from MDD to MDR compliance that has to be properly documented while ensuring the utmost data protection.
MDR: The Path to Improved Medical Device Safety and Efficacy
The MDR represents a significant regulatory shift, adapting to these new regulations is crucial for companies operating in the medical device industry, and often very difficult to document. qmsWrapper recognizes the challenges faced by medical device manufacturers during the MDR implementation process.
Extended Transition Period: Seizing the Last Opportunity for Compliance
The impact of the COVID-19 pandemic, coupled with the intricacies of the requirements, has presented obstacles for many organizations. In response to these challenges, the European Commission has proposed an extension to the MDR deadline.
The transition period, originally set to end on May 26, 2024, has been extended to December 31, 2027, or December 31, 2028, depending on the risk class of the device. This extension aims to provide manufacturers with more time to comply with the stringent MDR requirements while addressing supply chain disruptions, notified body capacity constraints, and economic operator readiness. For class III implantable devices, the transition time has been suggested to be extended until May 26, 2026.
qmsWrapper: Your Partner in MDR Compliance
At qmsWrapper, we understand the importance of supporting our clients in their journey toward MDR compliance. With our Spring Update, qmsWrapper offers an updated Quality Manual that is fully MDR compliant and very easy to customize, added procedures/processes, and templates that seamlessly integrate with the requirements. Our customizable workflows, powerful reporting capabilities, and automated tasks ensure efficient and compliant handling of changes while maintaining traceability throughout the process.
Enhanced Security: Safeguarding Your Data
qmsWrapper maintains appropriate industry-standard technical and organizational measurements to protect Customer Data. We monitor the changing cryptographic landscape closely and work promptly to upgrade our services. In addition to MDR support, qmsWrapper's Spring Update introduces enhanced security measures with advanced encryption protocols and comprehensive data backup systems.
Don't Miss Your Last Chance to Comply with MDR
As the MDR compliance deadline draws near, medical device manufacturers must take immediate action to ensure regulatory compliance. qmsWrapper is here to help you navigate the complexities of the MDR requirements efficiently and effectively. By appointing a person responsible for regulatory compliance, conducting a thorough gap analysis, updating technical documentation and labeling, and engaging with Notified Bodies, you can secure your path to compliance.
Let qmsWrapper be your trusted partner in achieving MDR compliance. Our Spring Update empowers you with the tools and resources necessary to streamline your processes, enhance collaboration, and meet the stringent requirements of the MDR. Don't miss your last chance to comply with MDR - take advantage of qmsWrapper's comprehensive software solution today.
To learn more about qmsWrapper and how we can support your MDR compliance journey, contact our team at firstname.lastname@example.org.
qmsWrapper is a leading provider of cloud-based quality management software solutions designed to streamline processes and enhance collaboration within the medical device industry. With a strong focus on compliance and efficiency, qmsWrapper empowers organizations to navigate regulatory challenges.