Compliance is a major concern shared by medical device manufacturers of all sizes. Every week, we talk to companies that struggle to keep up with the evolving regulatory landscape. Given the strict regulations and ever-increasing scrutiny at play, these companies seek a quality management software solution that can flex and adapt to regulatory changes in real time.
ARMATURE can help.
Roots in Standards & Compliance
For more than 16 years, we’ve had the privilege of building quality management software for leading organizations in the healthcare, manufacturing, and education sectors. Many of our early customers were (and still are!) both Standards Developing Organizations (SDOs) and Conformity Assessment Bodies (CABs). These customers required quality management software that could support the end-to-end process of developing a standard, revising it, and then carrying it through to conformity assessment, and they tasked ARMATURE with building a solution strong enough and smart enough to handle the curveballs that dynamic standards throw into the audit process. So that’s what we did.
This intimate understanding of both sides of the standards equation has inspired our quality management solution—one that makes it easy for medical device manufacturers to keep pace with changing regulations.
You Can Update Your System to Reflect Changes in Standards
ARMATURE’s web-based tools are designed to embed governance into the system—whether it’s a new standard, a revision to an existing standard, or additional criteria that you need to audit your suppliers against—and then tie it directly to the audit process so that your organization can start gathering data and measuring compliance right away. No holes in coverage, no delays in implementation.
Unlike other solutions on the market, ARMATURE hands you the keys and gives you the power to update your system to reflect regulatory changes as they occur. Because it was originally designed to be used by standards developers (who are not necessarily IT gurus), our system makes it easy for users to plug in new or revised standards, tie them to assessments, and begin tracking effectiveness right away. This functionality has powerful implications for medical device manufacturers who struggle to keep up with regulatory updates. With ARMATURE, you can—it’s what our system was built to do.
You might be wondering how this works in the real world of lengthy and complicated standards. If a standard is 300 pages long, how much does it really help you to house it in our system? ARMATURE streamlines the process for you: we allow you to store and reference the parts of the standards that apply to your organization and tie that governance seamlessly to your audits—so you can start collecting compliance data from your suppliers right away.
If the FDA releases an update to a standard, you can reference the applicable updates in our system, tie those updates to an audit checklist or another collection instrument, and deploy the updated audit to your auditors in a matter of hours. This gives you the coverage you need to demonstrate your commitment to compliance and the ability to report effectively.
The Power of the Audit: Self-Evaluation & Supplier Audits
While our standards expertise derives from our work with organizations that both develop and consume governance, we understand that a chasm exists between most SDOs and the industries they regulate. A new or revised standard might be ill-defined, and you might question how meaningful it is to your customers and suppliers.
That’s why audits and self-evaluations are so important. The quickest way to clarify a standard is by testing it in the field through audits. If you give a revised standard to five of your auditors and all five of them record failures, or if you get massively divergent responses, then there might be a problem with the regulation itself. It’s only when you see how the standard is interpreted through audits and self-evaluations, gathering data as you go, that you’ll be able to get a real feel for the new standard’s weight and meaning, and you’ll be better prepared to triage issues as they arise.
But the first step is knowing. When you can say, “We’ve audited our devices, and we’ve found ourselves to be deficient here and here,” you can then move closer to a solution. Perhaps you need clarification on the standards, or maybe you need to improve your processes to eliminate non-conformances and maintain compliance.
ARMATURE makes it easy for you to take whatever standards the regulatory bodies throw your way and fold them into your quality management software on the spot and in the moment. With our software in your corner, your audits will always be strong and effective, and in lockstep with the regulators.
Want to see our software in action? Schedule a demo today!