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Insights for Modern MedTech Quality and Regulatory Teams
Welcoming Jessica Castillo as CEO
A New Chapter for Grand Avenue Software: Welcoming Jessica Castillo as CEO Grand Avenue Software has spent more than two decades helping medical device companies…
How Can a MedTech Startup Get Audit-Ready Fast?
How Can a MedTech Startup Get Audit-Ready Fast? A MedTech startup can get audit-ready fast by implementing a purpose-built eQMS with out-of-the-box regulatory compliance, pre-built…
What Does a Class II Medical Device Manufacturer Need From an eQMS?
What Does a Class II Medical Device Manufacturer Need From an eQMS? A Class II medical device manufacturer needs an eQMS that supports FDA 510(k)…
Why Should CAPA, Complaint Handling, and Nonconformance Management Live in One System?
Why Should CAPA, Complaint Handling, and Nonconformance Management Live in One System? CAPA, complaint handling, and nonconformance management should live in one connected system because…
What Should a Venture-Backed MedTech Startup Look for in an eQMS?
What Should a Venture-Backed MedTech Startup Look for in an eQMS? A venture-backed MedTech startup should look for an eQMS that deploys in weeks, includes…
What is Total Quality Management (TQM)?
What is Total Quality Management (TQM)? Total Quality Management (TQM) was once a leading philosophy in quality management, emphasizing continuous improvement, employee involvement, and customer…
Why Modern Medical Device Manufacturers Can’t Thrive Without an eQMS
Why Modern Medical Device Manufacturers Can’t Thrive Without an eQMS: Five Reasons Digital Quality Systems Are Now a Competitive Necessity Nancy HansenGrand Avenue Software Medical…
Getting Your Medical Device to Market
Getting Your Medical Device to Market: Here’s What Really Works By Scott Nelson, Co-Founder and CEO of FastWave Medical The medtech market closed 2024 just…
Introducing Requirements Management in Grand Avenue 16.6
Introducing Requirements Management in Grand Avenue 16.6 Casie GlasmanProduct Manager, Grand Avenue Software Ryan MaishImplementation Success Manager, Grand Avenue Software Medical device teams are under…
Risk Management for MDR: Extending Beyond ISO 14971:2019
Risk Management for MDR: Extending Beyond ISO 14971:2019 Dr. Rachel Gibbs, PhD, BSc Medical device risk management is an iterative process that starts at the…
FDA calls for ‘Secure-by-Design’ cybersecurity for medical devices
FDA Calls for ‘Secure-by-Design’ Cybersecurity for Medical Devices By Steve Zurier The Food and Drug Administration (FDA) has brought to light an age-old problem with…
How Our Customer Advisory Board Drives Product Direction
Behind the Scenes: How Our Customer Advisory Board Drives Product Direction Casie GlasmanProduct Manager, Grand Avenue Software At Grand Avenue Software, we believe the best…
Agile Software Development at Grand Avenue Software
Agile Software Development at Grand Avenue Software: Delivering Software for Teams Who Can’t Afford Surprises Craig PetersonSenior Software Engineer, Grand Avenue Software At Grand Avenue…
Controlled Chaos
Controlled Chaos The medtech industry was left with more questions than answers this year amid policy shifts and lingering hurdles. Michael BarbellaManaging Editor, Medical Product…
Understanding Medical Device QMS Software
Understanding Medical Device QMS Software In the medical device industry, quality is more than just a priority—it’s a regulatory requirement. A Quality Management System (QMS)…
Quality Assurance vs. Quality Control Explained
Medical Device Quality Control Plans: Quality Assurance vs. Quality Control Explained Ensuring high-quality products is essential in any industry, but especially in the regulated field…
Quality Control for Medical Device Companies
Medical Device Quality Control Plans: The Basics For medical device companies, quality control is not just about maintaining high product standards—it’s a regulatory necessity. A…
ISO 13485: Understanding the Basics
ISO 13485: Understanding the Basics For medical device manufacturers, achieving ISO 13485 certification is essential for ensuring product safety, meeting regulatory requirements, and maintaining customer…
Medical Device Risk Management Tools
Medical Device Risk Management Tools In the highly regulated medical device industry, managing risk is critical to ensuring patient safety and regulatory compliance. Risk management…
What is Audit Management?
What is Audit Management? Audit management is the structured process of planning, conducting, and tracking audits to ensure compliance, mitigate risks, and drive continuous improvement….
ISO 9001 vs. ISO 13485 Certifications for Medical Device QMS
ISO 9001 vs. ISO 13485 Certifications for Medical Device QMS When implementing a Quality Management System (QMS) for your organization, understanding the differences between ISO…
What is a Quality Management System (QMS)?
What is a Quality Management System (QMS)? In highly regulated industries like medical devices, ensuring product quality and regulatory compliance is non-negotiable. This is where…
Best Practices for Document Management
Best Practices for Document Management & Control Procedures Effective document management and control are critical for ensuring compliance, security, and efficiency in any organization. Whether…
Understanding FDA Compliance for Medical Devices
Understanding FDA Compliance for Medical Device Companies Bringing a medical device to market in the United States requires strict adherence to FDA regulations designed to…
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