Posts Tagged ‘medical device’

The medical device industry is in a constant state of evolution. We are seeing more sophisticated consumer expectations, advancements in technology, regulatory changes, and changing healthcare needs – just to name a few. As we gaze into our crystal ball, five key trends have bubbled up. Let’s look at what is poised to impact the […]

In today’s ever-evolving healthcare landscape, patients frequently depend on medical devices to monitor their health, improve their quality of life, and manage chronic conditions. Effective communication plays a pivotal role in ensuring patients understand how to use their devices, stay informed about updates and maintain a healthy lifestyle. Salesforce Marketing Cloud offers a powerful solution […]

With surging inflation, decreased hospital spending, and widespread market uncertainty, it is vital that medical device organizations stay knowledgeable about the future of the industry, so they can prioritize their investments strategically.  As we begin the new year, we expect the following eight trends to drive the medical device industry in 2023. 1. Virtual Health […]

Customers’ expectations for their shopping experiences have drastically altered, largely in part due to Amazon. Gone are the days where you have to run to Foot Locker or Toys “R” Us to buy presents for your kids. Place an order online, and in some cases, get it delivered the same day. The COVID-19 pandemic forced […]

The Impact of Colon Cancer According to the National Institutes of Health (NIH), colon cancer is the third-leading type of cancer death in the United States. Cancer in the colon usually starts from polyps or other precancerous growths in the rectum or the colon (large intestine). As part of a colorectal cancer screening and surveillance […]

In a landmark effort to both guide and spur artificial intelligence (AI) and machine learning (ML) development in the medical field, the US Food and Drug Administration (FDA) has released an Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan. Background The plan was created by the FDA’s Digital Health Center of […]

This is the final post in our series on maintaining regulatory-compliant IT systems in the cloud. In this post, we’ll go over the key takeaways from the series and then we’ll send you on your way! Regardless of how much control you have over your IT systems, if you are using them for regulatory purposes, […]

As we’ve learned in the previous posts in this series, having a thoughtful, thorough cloud vendor qualification process and intelligent SLAs in your cloud vendor contracts will help you maximize the value of the cloud while maintaining regulatory compliance. In addition, here are some tips and best practices to help you knock it out of […]

In my previous post in this series, we discussed how to qualify cloud vendors. Once that process is complete, the second step to maintaining compliance is to document your specific regulatory requirements in a contract with the cloud vendor, usually in the form of service-level agreements (SLAs). In this blog post, I include a range […]

We recently completed a 21 CFR Part 11 gap analysis engagement for a client that was largely using SaaS applications, but had no cloud vendor qualification process in place. They had just been allowing each business unit to select the applications that met its user requirements, accept whatever validation documentation the cloud vendor supplied (if […]

Any time you take advantage of a cloud service – infrastructure, platform, or software – for a regulated purpose, you are ultimately responsible for its regulatory compliance, not the cloud vendor. This is critical for you to remember. So, how can you ensure regulatory compliance of a software system you did not build, you do […]

As we continue our series on maintaining regulatory-compliant cloud systems, let’s touch on a few key terms. Below are explanations of the primary cloud-hosted offerings available in the market. Infrastructure-as-a-Service (IaaS) When you purchase a software system and opt to have a vendor host it for you instead of installing it on servers you own, […]