Aug 25, 2021 Savvithri Sivaraamakrishnan

Bring life-saving medical devices to market faster with Qualio Design Controls

We’re excited to announce Design Controls, a new product in Qualio built on ISO 13485 and CFR 820 in harmony with ISO 14971, that enables product development and quality teams to work together and ship high-quality, life-saving products faster.

If you want to see Design Controls in action, sign up for our product walkthrough on Sept. 1

The biggest challenge medical device companies face today is bringing quality products to market quickly. Product development teams struggle with losing velocity because of fragmented tools and data sources they must depend on to ensure safe products.

The products companies are building are more complex than ever, and timelines compress as time-to-market and ability to scale are essential for success. This is being accelerated by today’s new breed of life sciences companies in areas like software as a medical device (SaMD), AI platforms and digital therapeutics.

These companies have a new set of needs, which require a new set of tools to be successful. And that’s what we’re building at Qualio. 

Unite your teams, tools and data

Quality can often feel like an opposing force to product development velocity. When friction exists between product and quality teams, quality seems like a blocker instead of what it actually is: a critical function that supports the product team’s efforts.

Product development and quality teams have historically operated across different tools and solutions. While product development teams work on requirements, needs and tests in their source systems like Jira, Azure DevOps and TestRails, the quality team might use their own custom spreadsheet-based tracking to manage quality processes.

This lack of cohesion makes collaboration harder and causes additional obstacles that could potentially lead to delays in product timelines.

Thanks to automation and powerful integrations, Qualio Design Controls removes the friction found in today’s product development processes. 

Design Controls helps medical device and SaMD organizations overcome these challenges by integrating with engineering systems and also offering APIs that allow teams to connect to their preferred tools. 

Maintain end-to-end traceability in real time

With your systems united in Design Controls, product development and quality teams can work together as partners with a single source of truth, enabling quality managers to easily assess risks (ISO 14971 and FMEA) and gaps and perform change control and design reviews.

Design Controls allows you to link artifacts from different systems and create traceability hierarchies directly in Qualio—from top level user needs through validation and verification. This functionality enables teams to easily conduct gap analysis and ensure compliance.

With the Design Controls dashboard, you can easily manage Change Control on all linked items with one click. With risk and change management assessed in one system, you can maintain a clear audit trail and end-to-end traceability for all product information—ensuring you stay compliant from the outset even when the product is being developed and is undergoing design changes.

No matter where requirements and product development happens, the relevant information is automatically captured within Qualio, enabling you to maintain traceability across design elements while your quality and product development teams work in their source systems.

Generate release documentation with one click

The painstaking work of manually collating quality artifacts in a spreadsheet or with paper is another barrier to faster product development. Many quality teams are used to a manual, error-prone process with few standard guidelines. 

Design Controls automatically compiles your artifacts into key documents like Risk Analysis, Requirements, Traceability Matrices and more, eliminating manual collation and tedious spreadsheets and ensuring teams deliver a safe and effective product to market with confidence and speed. 

Within Design Controls, you can easily produce output compliance records in a single click. Easily review and approve your quality artifacts with Part 11-compliant e-signatures, and then populate those artifacts in easily downloadable documentation. This eliminates time consuming paper-based processes and manual governance. 

Striking the balance between velocity and quality

There’s no reason quality and product teams have to see each other as opposing forces. In fact, quite the opposite: The better they’re able to work together, the more life-saving products we can all benefit from.

Design Controls enables medical device and SaMD companies to develop products with the peace of mind that comes with knowing quality is continually addressed — and never a blocker. In turn, teams can move at whatever speed they want to go, bringing high-quality medical devices to market faster than before.

To see how Design Controls can help your medical device company embed quality into the foundation of your processes, sign up for a live webinar with our product team.

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Published by Savvithri Sivaraamakrishnan August 25, 2021