Our blog navigates product development and compliance for the life science industry. Our solutions save time and money, delivering products with less risk.
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.
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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.
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.
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...
SEPARATE RISK MANAGEMENT AND FMEA FOR BETTER MEDICAL DEVICE DEVELOPMENT. The below is an excerpt of the article originally published on MDDI. FMEA (Failure Mode and Effects Analysis) is utilized to identify potential failure modes in the design or manufacturing of a product. But risks associated with medical devices are not created by failures alone. A product may never fail, but there are still potentially many other risks.