Skip to main content

Posts Tagged ‘medical device’

Elderly Patient With Bp, Heart Rate, Digital Pulse Check Equipment For Medical Geriatric Awareness In Stroke Systolic High Blood Pressure, Hypertension, Hypotension And Cardiovascular Disease In Aged Senior Older Woman Person

Salesforce Marketing Cloud Revolutionizes Medical Device Communication and Enhances Patient Outcomes

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 […]

Senior Man Consulting With His Doctor Online

Top 8 Trends Driving the Medical Device Industry in 2023

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 […]

Internet Shopper Entering Credit Card Information Using Laptop Keyboard

5 Insights From Our Ecommerce Conversation with Johnson & Johnson Consumer 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 […]

FDA Approves Marketing of AI/ML Device To Find Colon Cancer

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 […]

InForm

Overview of FDA’s AI/ML-Based Software as a Medical Device Action Plan

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 […]

Key Takeaways About Compliant IT Systems In The Cloud

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, […]

Tips And Best Practices For Compliance In The Cloud

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 […]

How To Use Contracts For Regulatory Compliance Of Cloud Systems

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 […]

How To Qualify Cloud Vendors

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 […]

Who Is Responsible For The Compliance Of Cloud Systems?

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 […]

Cloud-Hosted Terminology: Types Of Systems

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, […]

Refresher: Which IT Systems Are Regulated

If your company makes drugs, medical devices, or biologics (vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins), it is regulated. If your company is regulated, then every IT system you use to design, develop, conduct trials, manufacture, package, label, store, distribute, install, or service your products is also […]

Load More