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. 

We’re excited to unveil the latest evolution of the Grand Avenue Suite — version 16.6 — featuring the brand-new Requirements Management Module. Building on the powerful Risk Management Module introduced in version 16.4, this release empowers medical device companies to seamlessly track and manage both risks and requirements across the entire product lifecycle. 

With these two modules working in harmony, teams can drive innovation with confidence, ensure regulatory alignment, and accelerate time to market — all in one integrated platform. 

What does this mean for you? 

• End-to-End Traceability 
  For regulated industries like medical devices, proving that risks and requirements are accounted for — from design input to post-market surveillance — is essential. By integrating risk and requirements management, Grand Avenue 16.6 simplifies traceability, a core FDA and ISO expectation (think ISO 14971 + IEC 60601 harmony). 
• Reduced Risk of Costly Mistakes 
  When risk and requirements live in silos, gaps go unnoticed until it’s too late. Lack of integration is a common root cause of design failures and compliance issues. This release helps flag related items when changes are made to User Needs and Design Inputs to ensure downstream impacts are assessed.  
• Future-Proof Your Processes 
  As regulatory expectations grow and products become more complex (think combination medical devices), having modular, integrated tools isn’t just nice to have — it’s mission-critical.  

How did we develop these modules? 

These modules weren’t built in a vacuum — they were crafted in collaboration with a dedicated advisory board of industry experts. These tools were shaped by the people who use them. Throughout development, we worked side by side with industry experts to ensure the solution fits real workflows — not just regulatory checklists. The result is a solution that truly meets the needs of real-world users.  

To ensure compliance is baked in from day one, we aligned both modules with key regulations and standards, including ISO 13485, ISO 14971, and 21 CFR Part 820. The result? Tools that don’t just support your workflow — they help keep you audit-ready and aligned with regulatory expectations. 

What is to come?  

The days of managing risk and requirements on paper or in clunky, disconnected systems are finally over.  

We’ve already received excellent feedback from customers using the Risk Management module, and we’re excited to hear your thoughts as you dive into Requirements Management. Your feedback isn’t just appreciated — it directly shapes what we build next. 

Over the coming releases, you’ll see even greater configurability and expanded functionality, all informed by real-world use and real customer needs. 

At Grand Avenue, our mission is simple: deliver powerful, compliant, and cost-effective solutions for the medical device industry. We’re not just building tools — we’re building your competitive advantage. 

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