Grand Avenue Software的封面图片
Grand Avenue Software

Grand Avenue Software

软件开发

Saint Paul,MN 851 位关注者

Quality Management Software Solutions for Medical Products Companies and Med Device Innovators.

关于我们

Grand Avenue provides the industry-leading quality management software solution for medical product companies. We are the affordable, scalable, and efficient quality compliant eQMS deployed by med-tech innovators and leaders around the world. Our team has extensive experience in software development, Software as a Service (SaaS) delivery, and quality compliance, specifically for the life sciences industries. We work hand-in-hand with startups, emerging growth and established companies to navigate the complex regulatory affairs (RA) and quality assurance (QA) environment. With Grand Avenue, compliance is assured, your budget is preserved.

网站
https://grandavenue.com/
所属行业
软件开发
规模
11-50 人
总部
Saint Paul,MN
类型
私人持股
创立
2002
领域
ISO 13485、FDA、Quality System、Regulatory Compliance、Audit Management、CAPA、Complaint Handling、Design Control、Document Control、Nonconforming Materials、Training Management、21 CFR Part 11、Equipment Management、eQMS、quality management software 、Med device software、quality assurance、QA和RA

地点

Grand Avenue Software员工

动态

  • Congratulations to Virtual Incision ! We’re excited to recognize Virtual Incision for their transformative work in surgical robotics, now leveraging NVIDIA AI technology. This collaboration is set to enhance precision and efficiency in surgical procedures, paving the way for improved patient outcomes in the operating room. At Grand Avenue Software, we’re proud to support companies like Virtual Incision that are redefining the future of minimally invasive surgery. Kudos to the Virtual Incision team for leading the charge in innovative surgical solutions!

  • Is your medical device startup audit-ready? In the world of medical devices, compliance isn’t optional—it’s the foundation of your business. Whether you’re sketching your first prototype or preparing for market launch, a?structured quality management system (QMS) is essential. But in today’s fast-paced regulatory landscape, relying on paper-based or hybrid systems could put you at risk of?delays, compliance failures, and costly mistakes. Join us for an engaging webinar: "From Napkin Sketch to Market Launch: Why Delaying an eQMS Could Cost You" Date & Time: March 26, 2025 | 1 PM EST Hosts: Kate McMahon & Ryan Maish (ex-Zimmer Biomet, SafKan Health) where We’ll break down: ? The?critical differences?between a traditional QMS and an electronic QMS (eQMS) ? How an?eQMS eliminates costly error and saves audit prep time ? Why using?SharePoint and DocuSign as a workaround can backfire ? Real-world examples of?paper QMS compliance disasters ? An actionable implementation checklist to begin your transition to a?paper-based system to a streamlined eQMS Who should attend? ? Startup founders?in the medical device space ? Quality & regulatory professionals?navigating FDA and ISO 13485 compliance ? Product development teams?looking to streamline quality processes ? Anyone who is?new to the industry?and looking to learn more about quality Don’t wait until an audit is looming!?Learn how a modern eQMS can?save you time, reduce errors, and provide software integration to trend your data. Register here: https://buff.ly/LMSxEbL

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  • ?? Simplify Your Document Updates! Join us on Thursday, March 20th, 10:00 AM – 11:00 AM CDT, for a session on User Functions in Document Control. What You’ll Gain: ? Learn how to submit a Document Change Request (DCR) and collaborate on tasks. ? Understand best practices for approving a DCR and implementing DCR actions. ? Get practical tips to streamline document control workflows. Why Attend? Perfect for anyone responsible for initiating or updating documents who wants to ensure a smooth, compliant process. Don’t Miss Out: Register using the link in the comments to secure your spot!

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  • Congratulations to Laplace Interventional ! We’re thrilled to celebrate Laplace on raising $22M to advance their groundbreaking tricuspid valve technology. This achievement marks a significant milestone in improving cardiac care and patient outcomes. Laplace’s innovative approach is poised to transform valve therapy by integrating cutting‐edge technology into clinical practice. At Grand Avenue Software, we’re proud to support pioneers like Laplace as they push the boundaries of medtech innovation. Congratulations to the entire Laplace team on this impressive achievement!

  • ?? Master Document Control Coordination! Join us on Wednesday, March 19th, 10:00 AM – 11:30 AM CST for a session on Coordinator Functions in Document Control. What You’ll Gain: ? Learn how to manage Preliminary Coordinator Reviews. ? Understand best practices for Document Change Request (DCR) workflows. ? Gain insights into releasing documents with confidence. Why Attend? Perfect for coordinators and administrators responsible for document control processes. ?? Don’t Miss Out: Register using the link in the comments to enhance your document control expertise!

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  • ?? Streamline Your Document Control! Join us on Tuesday, March 18th, 10:00 AM – 11:30 AM CST for a session on configuring Document Control. What You’ll Gain: ? Learn how to configure document types, process impacts, and process options. ? Get hands-on guidance on importing documents. ? Understand best practices for managing document control workflows. Why Attend? Designed for teams managing compliance through effective document control practices. ?? Don’t Miss Out: Register using the link in the comments!

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  • Congratulations to Helius Medical Technologies, Inc.! We’re excited to celebrate Helius on establishing Revelation Neuro, a new BCI-focused subsidiary that aims to push the boundaries of neurotechnology. By launching Revelation Neuro, Helius is furthering its commitment to developing innovative brain-computer interface solutions that can transform patient care and improve lives. At Grand Avenue Software, we’re proud to support visionary companies like Helius as they continue to lead the way in cutting-edge neurotech. Congratulations to the entire Helius team on this bold new chapter!

  • Congratulations to MicroTransponder! We’re excited to celebrate Microtransponder’s recent milestone—securing $65M in funding to drive the advancement of their cutting-edge nerve stimulation technology. This investment underscores their commitment to transforming pain management and nerve repair with innovative, minimally invasive solutions. At Microtransponder, breakthrough engineering meets patient care. Their pioneering nerve stimulation tech is set to improve outcomes and redefine how chronic pain and nerve injuries are treated. We’re proud to support companies pushing the boundaries of medical innovation and enhancing lives worldwide. Congratulations to the entire Microtransponder team on this incredible achievement!

  • ?? Elevate Your Security Game! Join us on Thursday, March 13th, 10:00 AM – 11:00 AM CST for a session on Security Features. What You’ll Gain: ? Learn how to search for security events and manage user password resets. ? Get hands-on guidance on security reports and two-factor authentication. ? Discover best practices for maintaining data security and compliance. Why Attend? Perfect for IT, compliance, and security teams focused on protecting sensitive data. ?? Don’t Miss Out: Register using the link in the comments to secure your spot!

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  • 查看Grand Avenue Software的组织主页

    851 位关注者

    Ready to Streamline Compliance in the Medtech Space? Join our free webinar on March 26 at 1 PM EST, hosted by Kate (Shubert) McMahon, a seasoned medical device quality leader with over a decade of experience ensuring compliance in highly regulated industries. About Kate: Kate is an Implementation Manager at Grand Avenue Software, specializing in guiding startups and established companies through the transition to electronic Quality Management Systems (eQMS) to meet FDA, ISO 13485, and MDR requirements. Before joining Grand Avenue, she served as a Quality Manager at Sana Health, overseeing quality systems, CAPA processes, and regulatory compliance for innovative medical technologies. She also worked as a Senior Quality Consultant at ERI Group and spent over seven years at Zimmer Biomet, playing a key role in quality engineering, supplier management, and process validation. With deep expertise in audit preparation, document control, and compliance automation, Kate understands the challenges medical device startups face—and how an eQMS can streamline operations and ensure regulatory success from day one. What You’ll Learn: ? Why an eQMS is essential for both startups and established medtech companies ? How to reduce audit prep time, manage CAPA processes, and ensure regulatory compliance ? Real-world examples of paper-based QMS pitfalls—and how to avoid them ? Actionable steps to transition from a hybrid or paper-based system to a fully digital eQMS Don’t wait until an audit looms. Secure your spot and discover how an eQMS can help you save time, reduce errors, and accelerate your path to market success. Register here: https://buff.ly/dBS3VOT

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