Medical Device and Pharmaceutical Product Development and Compliance

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.

Medical device manufacturers face significant pressures to bring safer products to market faster. However, meeting critical project milestones and launch dates on time and within budget is becoming increasingly difficult. Medical devices are becoming more complex—which makes product development more difficult. At the same time, industry standards and regulations are evolving, placing new pressures on quality, regulatory, and engineering teams.

How can medical device manufacturers successfully balance the significant pressures of today’s market? On the one hand, they need to bring new devices to market quickly. On the other hand, devices are becoming much more complex, while at the same time, industry standards and regulations are continuing to evolve. During our recent webinar, three panelists—Nathan Brown, R&D Fellow at Boston Scientific; Mike Casper, System Engineer Manager at Smith & Nephew; and Eric Maas, a former Medtronic executive and founder of Six Sigma Experts—shared their perspectives on how medical device manufacturers can achieve speed to market, safely.

Most medical device manufacturers continue to rely on manual and Word/Excel-based approaches for design control and risk management—and that’s hindering their ability to achieve critical strategic initiatives, including improving efficiency and accelerating time to market.

A Q&A With Gerald Wesel, Cognition Chairman and CEO Gerald Wesel, Cognition’s Chairman and CEO, is responsible for setting the company’s strategic direction. He is known for propelling innovative, disruptive technology companies to next level success, and has previously served in leadership roles at seven startups and four large enterprises. In this Q&A, he provides his take on how medical device development is evolving—and the persistent and emerging challenges that device companies are facing as a result. He also shares some key strategies that device company leaders should be employing to help their organizations adapt and thrive.

Critical software functionality for every medical device development company Medical device development companies are increasingly recognizing the value of a purpose-built medical device design control software platform for delivering safer products to market faster, with less risk and less cost. Robust documentation processes, provided via an effective software platform that supports audits and more, ultimately lead to higher-quality products.

Risk analysis is crucial for ensuring safety and efficacy, but a recent survey of 100 medical device development and quality leaders revealed that many lack confidence in their current risk analysis processes.

When it comes to medical device development, efficiency, speed, and accuracy are gamechangers. The faster you can move without sacrificing safety or quality, the quicker your time to market and the sooner your impact on patient care.

Save time and money by addressing regulations early and often Medical device engineers are tasked with developing innovative and safe products while meeting a multitude of regulations in an ever-changing landscape. Meeting these regulations can be challenging and expensive, especially for startups and smaller companies. Here are 10 ways to help medical device engineers meet regulations without wasting their design budget or timeline: