Regulatory

FDA ISO QMSR Harmonization

Prepare for FDA’s ISO 13485 harmonization with MasterControl Quality Excellence, the #1 QMS in the life sciences

The U.S. Food and Drug Administration (FDA) is taking steps to harmonize 21 CFR Part 820 with ISO 13485. Prepare for the new Quality Management System Regulation (QMSR) with MasterControl Quality Excellence, an electronic quality management system (eQMS) that lets you quickly make changes and implement them. Download the data sheet to see how you can easily manage documents, training, quality events, and audits seamlessly on the same platform.

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21 CFR Part 820 – ISO 13485 Harmonization

FDA QMSR Frequently Asked Questions

Why is QMSR harmonization important?

FDA QMSR will make it easier for companies to sell in multiple markets. For the FDA, ISO 13485 harmonization is a way to lessen the burden for medical device companies so they can comply more easily with U.S. regulations and ISO standards.

What are the challenges and barriers to QMSR harmonization?

The changes to 21 CFR Part 820 will mostly be problematic for companies that don’t already follow both U.S. regulations and ISO 13485. Even so, the changes are mostly related to only a few sections of the regulation which are outlined in the FDA’s proposed rule.

How does QMSR harmonization align with international standards and regulations?

The FDA ISO 13485 harmonization is part of a larger worldwide effort to better align regulatory requirements across countries. These efforts make it easier for medical device companies to comply, which means markets will get access to devices sooner than they otherwise would.

How can medical device companies navigate the harmonization process effectively?

Part of the harmonization process is updating your company’s quality management system, especially the documentation. An eQMS that lets you integrate managing documents, training, quality events, and audits will help you efficiently make changes and ensure nothing slips through the cracks.

What To Look for in an eQMS

An eQMS that lets you make changes quickly and connects all quality processes is best suited for any regulatory change, including the new FDA QMSR.

Document management with built-in version control

Getting everyone on the same page is difficult if you have trouble ensuring you’re using the most recent page. An eQMS that automatically archives old versions of documents ensures that everyone can access the newest version and only accesses that one.
Automated training

Whenever something changes, you have to ensure the proper employees are trained on those changes. An eQMS that connects documents to training can do this automatically by sending out training tasks and following up without human involvement.
No-code configurability

How you manage quality processes and quality events can be unique to your organization. An eQMS that provides a simple user interface that lets you quickly and compliantly design a workflow is essential to keeping up with changes.
Advanced analytics and reporting

Having all quality-related information in a centralized location is a good start, but being able to use that data is much better. Rather than exporting your data to another tool, choose an eQMS that lets you analyze the data in the software, no exporting required.
Easily track, manage, and pass audits

With all documentation together, you can easily pull up the most recent version of a document when an auditor requests it. An eQMS should also give you the ability to easily schedule audits and make any associated changes to your quality processes.

Find out how MasterControl eQMS prepares you for change.

FDA ISO 13485 harmonization is just one example of the changes that are always happening in the medical device industry. Learn how MasterControl’s Quality Excellence can help you keep up.

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Medical Device eQMS Resources

Select all the resources you’re interested in downloading.

Research Report: The State of Digital Quality Maturity in Pharma and Medtech
Buyers Guide: QMS Buyer’s Guide: Finding the Right Fit for the Future
Ultimate Guide: The Ultimate Guide to Medical Device Quality Management
White Paper: Understanding ISO 13485: 2016 — A Brief, Yet Comprehensive, Overview
FAQ: 21 CFR Part 820 – ISO 13485 Harmonization
Solution Overview: MasterControl Quality Excellence

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FDA ISO QMSR Harmonization

FDA QMSR Frequently Asked Questions

What To Look for in an eQMS

Document management with built-in version control

Automated training

No-code configurability

Advanced analytics and reporting

Easily track, manage, and pass audits