Resources
Get familiar with common QMS topics
FDA Calls for ‘Secure-by-Design’ Cybersecurity for Medical Devices
The FDA urges medical device manufacturers to adopt a “secure by design” cybersecurity approach. This article outlines expectations for proactive security throughout the product lifecycle, from development to post-market.
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Accessing Grand Avenue Software Training & Support Resources
Get the most out of Grand Avenue Software with quick access to training videos, FAQs, live sessions, and in-app support tools. Whether you’re just getting started or exploring advanced features, our resources are built to help you learn, stay compliant, and work efficiently.
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How Grand Avenue Software Safeguards Your Data
Discover how Grand Avenue Software protects your sensitive quality and compliance data through robust encryption, access controls, and secure cloud infrastructure. Our commitment to data security ensures your organization stays compliant with FDA, ISO, and global regulatory standards.
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Risk Management for MDR: Extending Beyond ISO 14971:2019
This article explains how medical device manufacturers must go beyond ISO 14971:2019 to fully comply with EU MDR risk management requirements, emphasizing that all risks must be reduced as far as possible — not just those deemed unacceptable.
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Introducing Requirements Management in Grand Avenue 16.6
Medical device teams are under pressure to innovate faster while meeting stricter regulatory demands. In version 16.6, Grand Avenue introduces the Requirements Management Module- a leap forward in connecting risk and requirements in a single system.
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Getting Your Medical Device to Market: Here’s What Really Works
Scott Nelson, Co-founder and CEO of FastWave Medical and founder of Medsider, shares key lessons learned on the path to medtech market adoption.
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Quality Assurance vs. Quality Control
Learn the differences between quality assurance and quality control (QA vs QC) and how to effectively implement both approaches in your operations.
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What is a Quality Management System (QMS)?
Is it a process or a software? Explore the essence of QMS’ and understand its definition, function and importance in effective quality control practices.
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Medical Device Risk Management Tools
Learn about risk management tools for medical device professionals, and how they enhance risk assessment practices and ensure compliance.
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ISO 9001 vs. ISO 13485
Explore the key differences between ISO 9001 and ISO 13485, including scope and applicability within the medical device industry.
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ISO 13485: Understanding the Basics
Delve into the key concepts, benefits, implementation strategies and fundamentals of ISO 13485.
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Medical Device Quality Control Plans: The Basics
Discover the essential components and steps involved in creating an efficient medical device quality control plan.
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Medical Device QMS
Discover the essential components and steps involved in creating an efficient medical device quality control plan and the role of QMS software.
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Understanding FDA
Medical Device Regulation
Learn about the key components of FDA regulations and classifications for medical devices in this comprehensive guide.
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What is Audit Management?
Learn about what audit management is, types of audits, best practices, key components, benefits and features to look for in audit management software solutions.
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