Mobile and FDA Compliance: New Regulations in 2018

Posted by Romeo Elias on Tue, Jun 19, 2018 @ 02:00 PM

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Things change very fast in the world of mobile apps. Besides the mobile phone manufacturers adding better cameras, processors, accelerometers, and gyroscopes; mobile app developers are following those upgrades up with new and improved apps. When talking about mobile medical apps, you probably wondered if the FDA regulates them. The answer has been changing, and we will present some of the latest rules brought by the FDA to make the picture somewhat more transparent.

Groups of Apps Regulated by the FDA

Before you conduct a regulatory assessment, you should determine whether your mobile app is affected by FDA's regulations. The FDA has been evident in their mobile medical app guidance that they intend to use a risk-based approach when applying their rules. Mobile medical apps that could pose a risk to a patient’s safety or health are the only ones the FDA regulates. There are four possible groups of apps, following the FDA’s way of sorting them:

  1. The app is not a medical device,
  2. Even if it is a medical device, the FDA has said that they will not regulate it,
  3. The FDA will regulate because they said that it is an app, and
  4. None of the above.

Apps that fall into groups 1 and two are not regulated by the FDA, while apps from the fourth group are those without analogs in any known examples. Apps from the group 4 are likely to be controlled. It is explained in the FDA’s “Guidance for Industry and Food & Drug Administration Staff” guidance document.

More Challenges with Proving FDA Compliance

The surge of mobile healthcare apps is the surge behind FDA’s regulatory updates and changes in medical app development. According to the Mobile Medical Applications Guidance for Industry and Food & Drug Administration Staff guidance, a medical app is considered to be an app that works as an accessory to transform a mobile medical platform for a form of medical use or augment, supplement, or support an existing medical device. To ensure the effectiveness and safety of medical apps, the FDA will use the same risk-based approach that it uses for other medical devices.

The Emergence of the De Novo Pathway Trend

PMA (Premarket Approval and 510(k) pathways for putting a product on the market have been more popular than De Novo pathway, but this is changing. It is happening because the FDA is streamlining the application process without requiring a 510(k) anymore. What De Novo method provides is a way to classify new medical devices as Class I or II when there’s no predicate device. If a person believes that their medical device is appropriate for classification into these two Classes, they can submit a de novo request without preceding NSE and 510(k). The De Novo pathway is highly risk-based, which means that you can get a product on the market without a lengthy premarket approval application (PMA.) It is only if your new technology isn’t considered high risk and you’re able to demonstrate how all known risks can be mitigated.

New and innovative ways for health improvement and better health care delivery are being opened with the widespread use and adoption of mobile technologies. The FDA is there to encourage mobile medical app development and has a responsibility to oversee their effectiveness and safety. If you’re conducting a digital transformation to be FDA compliant with all new regulations and laws, involve your compliance team to ensure alignment from the beginning.

 

Tags: mobile apps, mobile applications, mobile compliance, FDA, FDA compliance, Regulations, FDA regulations, new regulations

Benefits of Access: Capturing Quality Data on Manufacturing Mobile Apps

Posted by Romeo Elias on Wed, Mar 07, 2018 @ 09:33 AM

 

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The ability to use mobile devices on factory floors and laboratories is transforming many aspects of manufacturing in highly-regulated manufacturing industries such as pharmaceutical, nutrition, and medical.

Regarding healthcare, mobile devices have become so common that there’s been rapid growth in the development of medical software apps. These apps assist health care professionals in communications and consulting, data and time management, health record maintenance and access, patient monitoring, education and training, and even clinical decision-making.

Many manufacturing companies have seen how mobile devices have revolutionized the healthcare industry and are now also leveraging mobile technology with the intent to use them increasingly in the monitoring of production and to ensure factory efficiency and safety.

In the past, computing and communications meant having to rely on multiple devices which included pagers, PDAs, and cellphones that could only make and receive calls. With today’s smartphones, you have all the capabilities of those electronics in one device. But beyond the ability to make voice calls and send texts, today’s smartphones and tablets have browsers, GPS, sound recorders, and high-quality cameras. And most importantly, access to industry-specific apps.

With smartphones and tablets, you can now capture data and get quality assistance from ultimately anywhere. The ability to capture everything from deviations during sampling and testing to calculating batch measurements in real-time means that non-conformance and corrective actions can be enforced almost immediately. Also, having offline capability to still capture data on mobile if there is no internet connection can help with situations where the factory floor doesn’t have good reception on the mobile device.

In manufacturing, the significant benefits of allowing workers to bring their mobile devices to the floor are giving them the ability to contact other employees, communicate with off-site personnel, and reference manufacturers’ documents. With mobile technologies, there is a significant improvement in logistics and supply chain coordination with suppliers. Customer responsiveness is enhanced thanks to the capability to integrate mobile CRM systems with order management, pricing, and fulfillment.

This improvement in efficiency is saving manufacturers significant sums of money each year. It may seem trivial when you think about how the reduction in time wasted between capturing the information and relaying it to the relevant people is a matter of minutes. However, consider how much valuable time is lost every year when you add up all those lost minutes that ultimately equate to hours, days, and weeks of misspent time. This could have easily been avoided if everyone was equipped with a mobile device that allows them to deliver up-to-the-minute data.

Factory environments are also becoming increasingly safer as workers have access to relevant and real-time data which traditionally, was confined to a desktop in the control room. Access to real-time adjustments and improvement in supplier traceability of critical materials means having the most accurate information, ensuring extra levels of safety and enhancement in quality levels.

Highly-regulated manufacturing industries such as medical products need to be constantly calibrated. With mobile-based sensors, data is captured and reported in real-time to production, allowing quality engineering teams to immediately act and ensure the floor is continuously in compliance.

Thanks to these realizations, manufacturing landscape is changing and CEOs are embracing digital transformation, prioritizing the importance of mobile technologies in the form of mobile apps and integrating them in their strategies, procedures, and processes to increase accuracy and speed to production centers. The goal is to deliver better communication, promote collaboration, and increase responsiveness to deadlines and delivery dates.

 

Tags: mobile apps, mobile applications, quality, quality data, mobile web, Quality Management Software, QMS, Quality Management System

EMPLOYEE SETUP APP:  Learn hOW TO AUTOMATE ONBOARDING BEYOND HR

Posted by Romeo Elias on Wed, Sep 30, 2015 @ 02:23 PM

The Employee Setup application is a modern enterprise app that makes it easy to onboard new employees by automating onboarding beyond HR.  As a compliment to your core HRIS system (ADP, Workday, Oracle, HCM/PeopleSoft, etc.), the app is designed to automate and streamline the process of setting up a new employee upon agreement of employment, with established work item requirements, while reducing the time-to-productivity. The purpose of the application is to automate the manual checklist/tasks managers use when a new hire comes on board, ensuring nothing gets overlooked or delayed, in turn, increasing the level of productivity and employee retention.

The app will provide the ability to clearly align new hires with key business strategies, while standardizing and individualizing new hire elements. The Employee Setup App is ideal for organizations with a high volume of new hires annually, or with high turnover, and enables high efficiency, productivity, and compliance.

The Employee Setup app is a pre-configured; ‘out of the box’ solution built on the Intellect Platform, and offers customization and integration functionalities. The Intellect BPM Platform empowers everyone to innovate by giving people the ability to build and deploy a wide variety of enterprise business apps rapidly, without the need for programming from design to launch. With Intellect’s agile development methodology, users are enabled to easily create web-based enterprise apps with smart forms, integrated enterprise data, automated workflow, advanced reporting capabilities, and the ability to go mobile in just minutes.

 

 

Watch Recorded Webinar 

 

What Attendees will learn:

  • How to automate over 30 manual tasks with the Employee Setup App before your new hires first day of work.
  • How the Employee Setup App will lead to increased employee productivity and lower turnover, saving your company both time and money
  • How to customize the Employee Setup App to directly align and integrate with your HR, HRIS, and hiring processes
  • Integration with DocuSign when there’s a need for eSignatures

Who should attend:

  • HR Executives/VPs/Directors/Managers
  • CIOs and IT Executives
  • Departmental Heads
  • Companies with High Turnover

 

Tags: BPM, Mid Market, Business Process Management, Cloud, HR, HR Gap, mobile applications, Workflow and Business Process Management, mobile apps

An Intern's Experience with Intellect

Posted by Kyle Fratello Hakim on Mon, Jul 28, 2014 @ 10:41 AM

I joined Interneer as a summer Sales Development intern on May 21st. A local college student at USC, I was to be responsible for identifying and creating new qualified sales opportunities for Account Executives, and spent my first few days on the job simply trying to comprehend what exactly the broad Business Process Management (BPM) field encompasses.

After a few hours (quickly days) of reading whitepapers and watching demos of Interneer’s Intellect platform given to potential customers, I finally had a simplistic understanding of BPM. In order to sell Intellect, however, I wanted to be able to direct customers to specific abilities that were unique to Interneer’s offering.

My need for differentiators led to my request for a live test site on June 13th, a Friday, at around 4 PM. The test site would allow me to build apps and automate workflows as if I were an Interneer customer.

By 5:01 PM, about an hour later, the first entry in a job application app I had built was present. While it wasn’t revolutionary, my job application automation program was built in less than an hour, and accepted responses instantly when completed. Hypothetical applicants were automatically assigned random application numbers for reference purposes, and could upload resumes, provide links to LinkedIn profiles, and mention a point of reference within the company.

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I was surprised at my ease in leveraging some of Intellect’s more impressive capabilities, such as automatically populating the list of options for the applicant’s point of reference with current Interneer employees in the company system. 

Just an hour after receiving login credentials to my live test site, I, a summer sales intern who arrived void of knowledge as to what BPM was, yet alone how to implement it, was already able build a basic app. The only training I had received prior to my endeavor was gathered simply by listening in on past demos, which are publicly available for viewing on Interneer’s website (here), that were given to potential customers.

Interneer markets itself as the BPM for the business analyst, and I could not agree with this more. Who better to have build apps than the people who will use them and understand what they want out of them? Clearly, my case demonstrates the ease of picking up the platform. If a steep learning curve is a source of hesitation for business analysts, I can, and will testify that building, and learning to build, applications using Intellect is intuitive, and dare I say it, fun.
 

Intrigued? Schedule a free demo!

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Tags: BPM, Business Process Management, Hosted Workflow, mobile applications, mobile apps, project tracking