The deadline for the official implementation of the EU Medical Device Regulation (MDR) is approaching. By May 2020, your medical device organization must be in compliance with many new requirements for your product throughout its life cycle. With this increased focus on the total product life cycle comes an expanded suite of regulations for postmarket surveillance you must be in compliance with. There is a lot to unpack in this aspect of EU MDR, but there are some major compliance areas your organization should be putting in place now.

NAVIGATE2019, Cognition’s annual user conference, has officially wrapped up. We heard many great talks, panels, and discussions over the course of the two-day event. Here’s a brief overview of the conference—what we discussed, what we learned, and how that information will impact Cognition moving forward.

Drug stability reporting has been a major area of interest for Cognition as of late. To get a better understanding the current environment, we coordinated our Summer Internship Program around this topic. Led by our interns Olivia O'Brien and Brigitte Cronin, this effort has yielded a vast amount of important and intriguing insights about the current state of drug stability reporting in pharmaceutical industries. Here are a few of those insights and what they can tell us about this vital aspect of pharmaceutical compliance.

The new European Medical Device Regulation (EU MDR) is on its way. Soon, medical device manufacturers wishing to submit to European markets will need to comply with a set of new and critically important regulations. However, even with the 2020 deadline coming up, many organizations are still in the dark about what the MDR is and what it means for them. Here are some common questions we’ve heard about this new European regulation and what it means for your product development and compliance activities.

There’s so much work that already goes into the development of life science products before even thinking about the necessary compliance steps. This high volume of work often leads development teams to push away compliance activities until later on, which can actually lead to rework and other negative consequences. Yet one compliance avenue that can get folded into this shuffle is your product’s use specification.

So, you’ve decided to adopt a compliance software tool into your life science organization as part of your product development activities. Congratulations! Now that you’ve made that big decision, here comes the tough part: transition and implementation.

Does your life science organization need to adopt a compliance software tool?

Many organizations tend to stick with what’s worked for them in the past for regulatory compliance due to its complexities and the need to assure that new products are safe and effective. This is especially true when it comes to compliance activities such as design controls. While this attitude is understandable, it does present some problems. It can limit an organization’s ability to remain competitive in the market, and it can also impede long-term business growth.

In July 2019, Ed Margerrison and Hilda Scharen of CDRH released information on FDA Voices about how the agency is working to increase the pace of medical device innovation. By using sound science and proven methodologies, FDA plans to work with device manufacturers to get beneficial products to market faster.