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:

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.

“The Only Constant in Life Is Change.”- Heraclitus Managing information goes straight to the heart of managing change. Why? Because without a rationale, checks and balances, evidence, and assurance of safety, information change – if left unchecked – can potentially lead to hazardous situations. This is especially critical in the intensely regulated medical device industry.

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.