Medical Device and Pharmaceutical Product Development and Compliance

Medical devices are becoming more complex, more connected, and increasingly used in home settings by people with varying levels of technical skill. Designing for safety isn’t just good practice—it’s a regulatory and ethical imperative.

If you missed our recent panel discussion, “From Concept to Compliance: Navigating Risk and Regulatory Submissions Across the Life Sciences,” the full recording is now available to watch on demand.

In the medical device industry, where precision and compliance are paramount, staying ahead of regulatory changes is critical. With FDA finalizing the alignment of its Quality System (QS) regulation with ISO 13485 by February 2026, medical device companies need to act now. This alignment has been expected as the international standards and FDA regulations have been converging for Quality System expectations for years. Since FDA announced its intent to align with ISO 13485 in 2018, the change should not be a surprise to medical device companies, but the implementation still requires careful and detailed attention to specifics. Fortunately, solutions like Cognition Corporation’s Compass MED provides a proactive way for companies to navigate complex regulatory landscapes and stay compliant from the start.

How a risk-based design approach provides safer and ultimately better quality products to market. Product designs are stronger when risk is inherently considered. Not everyone has the experience and instincts to naturally consider the critical factors required in a comprehensive approach. A solid process ensures risk is addressed consistently throughout product development by all of the stakeholders. It is not enough to intuitively consider risk when designing a product; decisions need to be articulated and documented - this documentation is used to support the design choices throughout the product's life.

Medical device development is a complex process, with a critical element focusing on risk management. The consequences of not managing risk properly can be catastrophic.

An introduction to how smart data utilizes information and actionable context to support business-critical decisions.

In the highly regulated world of medical device manufacturing, the relentless requirement to minimize and mitigate risk places a huge onus on design, development, and manufacturing teams. That’s why companies, large and small, are looking for software solutions to help ensure consistency and objectivity in the creation, auditing, and monitoring of critical risk management processes.

Key takeaway: The ability to reuse product data can dramatically reduce the time taken to design, gain regulatory approvals, and ultimately bring new medical devices to market. Time equates to money in any business, and in the world of medical device design and manufacturing, that can mean BIG numbers! Depending on the route taken, following FDA regulations, the average cost to bring a medical device to market through the Premarket Approval pathway is $94 million. The less intensive 510(k) process averages out at $31 million.

Using unstructured tools such as Word and Excel when doing risk management for medical devices could result in harm to a patient. Why? Because many medical devices are complex, with hundreds to thousands of inter-related design inputs/outputs, testing, and risk management data. Managing that amount of data manually is nearly impossible when using tools like Word and Excel...