Navigating Medical Device Design Control & Risk Management
Helping you navigate integrated design control and risk management, while providing complete visibility into the entire development process for your medical device.
Our lives are rapidly evolving, thanks in part to the technological revolution of our current age. As our way of life changes, so too does the healthcare required to support it. This is forcing a massive disruption in the medical device industry. The user needs of the past are giving way to new ones, and planning for the changes now helps your organization prepare for the future of medical devices.
Auditing is often a four-letter word in life science product development; even if you’re conducting one internally, audits can be a dreaded experience. However, they don’t have to be—especially if you’re using the right software. Here are five features of product development software you should be looking for when it comes to auditing activities.
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So, you’ve decided to adopt a compliance software tool for your life science organization. Congratulations! However, you’re only at the start of a big implementation process—one that has a lot of moving parts and work attached. How do you make the start of using compliance software the best process it can be?
Risk management is crucial in life science product development, but, like any other activity, it can become burdensome. It can also complicate your product’s design past the point of feasibility for both production and use. Too much risk management and your teams are stuck with piles of mitigations and controls to manage; too little, and your product may face rejection during the premarket notification process or force CAPAs in postmarket environments. Neither of these options is ideal, but how do you find that “Goldilocks” zone?
We’re getting close to the end of the year, and FDA is still working at a solid pace. Here are some of the interesting updates in October 2018 we think are worth checking out.
The price of industrial robotics continues to fall, and advances in computing—AI, deep learning, software automation, etc.—are accelerating. As a result, we’re moving towards a new era of mass production and manufacturing known as Industry 4.0. But what does this new age of industry look like, and what does it mean for medical device manufacturing?
Cybersecurity is a growing concern for FDA and other regulatory bodies when conducting reviews for medical devices. As instances such as the WannaCry cyberattack have shown, there are real, persistent threats to global health systems, and interconnected devices with cybersecurity vulnerabilities can exacerbate these attacks. Therefore, it’s critical to identify these vulnerabilities and control their risks.
Developing user needs for your life science product: is it just about capturing input from your stakeholders and translating it into requirements?
Across industries, robots are more prevalent in the manufacturing process than ever before. Skilled labor is steadily being replaced as labor costs rise and technology prices fall. As a result, we are moving toward a world where machines—not humans—are the primary workers on the production line. But what impact can this shift have on your medical device manufacturing processes?