The market for digital health products is rapidly expanding. Reports from Global Market Insights, Inc. project the value of this marketplace to expand to $504.4 billion by 2025. Many life science organizations have seen the opportunity these technologies can provide and are jumping at it. However, this boom in the industry has not gone unnoticed; in recent years, FDA has been rapidly transforming their policies and organization to handle the necessary regulatory work these digital health products bring to the table.
Your product’s intended patients have a wealth of experience and information that can be valuable to your development process. Whether it’s the day-to-day realities of the condition, the symptoms they feel need the most attention, or things they might be missing in their current treatment regimens, this data cannot be elicited from doctors and engineers alone.
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FDA Form 483 Inspectional Observations are one of the many tools the agency uses to verify medical device products do not expose users and patients to undue risk. Many of the commonly cited observations involve some aspect of design controls regulations, which is of particular concern for development teams and manufacturers. Of the 438 inspectional observations in FY2017, FDA cited three design controls regulations more commonly than all others:
Deciding to adopt a compliance software tool is not always a straightforward process. There are a number of aspects that need to be addressed—potential quality system issues, user adoption, and so on. Despite these concerns, however, there are some clear benefits to software adoption that should be taken into account. From improving documentation to establishing greater accountability, there are four distinct reasons to consider adopting compliance software.
By May 2020, the new European Union Medical Device Regulation (EU MDR) will be fully implemented. Medical device manufacturers now need to comply with a set of new and critically important regulations. While this deadline is fast arriving, there is still time to plan ahead. To make that planning as effective as possible, there are several key approaches your organization should think about taking.
There are many reasons why life science organizations choose the Cognition Cockpit Platform for their design controls and risk management activities. Cockpit’s numerous functionalities and features have been deployed by businesses large and small, and to great success. But what were the deciding factors for those organizations, and do they make sense for you?
Do you want to improve your design controls documentation? If so, the first step is to evaluate how your current processes and procedures are working and how effective their results are. To work through this process, there are six important questions to ask, ranging from your design outputs and risk management to the current state of your product data across multiple sites. Answering these questions thoroughly and honestly can empower greater levels of design controls compliance in your premarket submission activities.
Generating and managing your compliance documentation for premarket submission takes a lot of time and effort. And when there are inconsistencies or other major issues, especially when it comes to design controls, a number of adverse effects could impact your organization. From time lost to remediation to delays to market, it can seriously cost your life science organization. To combat these issues, you can use a number of tactics to improve your design controls documentation.
Internal auditing is an important activity for life science organizations not just during product development, but through the overall product life cycle as well. It allows your business to self-monitor according to the necessary quality management system (QMS) rules and requirements laid out by FDA and other regulatory bodies. But some organizations might find themselves struggling with this compliance aspect: how do you ensure your internal auditing is up to standard? Here are four steps you can take to improve your auditing capabilities and efficacy.