AssurX is participating in the first virtual RAPS Convergence Conference currently live through September 16, 2020, in Virtual Booth 610. RAPS Convergence brings together the largest community of regulatory professionals from the medical device industry.
AssurX is always pleased to be part of the nucleus of experts that brings insights for addressing and overcoming challenges caused by disruptions to the industry.
Countdown to EU MDR: How prepared is your organization?
In 2020, the COVID-19 Pandemic has by far been the largest tech disruptor. So much so that The European Commission (EC) delayed the EU MDR compliance deadline until December 2020. According to the EU, the delay is to allow manufacturers enough time to address critical gaps in the need for transparency and meet the demands placed on limited notified bodies.
By December 2020, in general terms, manufacturers must be ready to demonstrate total life cycle traceability from product development through post-market activities. While this is no short order, EU MDR by design will improve quality standards for device manufacturing. Building the correct system of technology, people and processes can create transparency for informed decision-making and issue management using scientific data and risk measurement.
AssurX offers an EU MDR Solution designed with pre-configured workflows and automated Manufacturing Incident Report generation. The solution is built to adapt to the unique and changing compliance needs for marketing products in the EU market. AssurX software can run standalone or integrated with the AssurX post-market surveillance quality management system for unmatched visibility into the device history. Extend the linkages of your quality system by integrating with key source systems to centralize data in a secure repository for downstream activity such as post-market investigations and reporting.
Attending RAPS? Visit the Virtual AssurX Booth to take our EU MDR Readiness Survey and you’ll be entered in our drawing to win a $50.00 Amazon Gift Card. Your insights will help provide a better perception of the true state of compliance readiness in the industry.
FDA Compliance: Automating EMDR Report Generation and Submission
AssurX EMDR automates FDA Medical Device Safety Reporting by providing a closed-loop automated reporting system for adverse event reporting without the requirement of any additional third-party tools or EDI systems. It enables full compliance with FDA CFR 21 Part 803 reporting guidelines for medical device manufacturers and device user facilities to report adverse events concerning device-related death or serious injury, or malfunction.
AssurX eMDR automates the generation and submission of electronic medical device reporting (EMDR) for MedWatch 3500A reports direct to the FDA Gateway. By using an intuitive, tabular workflow approach, AssurX provides all levels of 3500A reporting, seamless direct submission to the FDA’s Electronic Submissions Gateway as well as PDF generation.
AssurX MIR and eMDR solutions can integrate with any other AssurX solutions including complaint management, CAPA, deviations, and change management to build a robust ecosystem that closes the loop on issue management and improves compliance readiness.
The AssurX Cloud for Medical Device Manufacturers
Another disruption caused by COVID-19 was a slow-down or stoppage of work when shut down orders impacted businesses across the country. The medical device industry was forced to take a new look at the benefits of cloud computing vs. brick and mortar offices.
While on-site jobs will always be necessary for certain personnel, the pandemic left scores of essential workers unable to perform their jobs. Businesses raced to install and update VPNs and establish connectivity – and subsequently manage a deluge of support calls. Bandwidth issues brought connections to a crawl. A cloud platform would have eliminated weeks of time and expense and the impact would have been significantly minimized.
The AssurX Cloud QMS provides all the functionality and features of AssurX’s quality and compliance management platform for medical device manufacturers. The enterprise-grade cloud environment delivers powerful performance and security in a managed environment with an extensive range of benefits.
Learn More: Speak with an AssurX Representative at RAPS
If you are registered for RAPS Convergence and would like to speak with an AssurX representative, request a live chat through the RAPS Portal.
Representatives are available during the following times:
- Tuesday, September 15: 10:30 – 11:00 am ET
- Tuesday, September 15: 12:30 – 1:00 pm ET
- Wednesday, September 16: 11:30 am – 12:05 pm ET
Not attending RAPS? Request additional information or a live demo at a time that works best for your team.