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QUALITY AND COMPLIANCE

How to Improve Your Quality Management With Internal Audits

Internal audits can help you improve your quality management. Discover techniques and overcome obstacles using Arena’s QMS solution for easier compl...

How to Classify Your Medical Device Under the EU MDR and IVDR

This article reviews the classification criteria established by the EU MDR and IVDR and provides steps on how to accurately classify your device. ...

Five Key Issues to Consider as Your Company Addresses FDA 21 CFR Part 11

It is possible to achieve FDA 21 CFR Part 11 compliance while implementing an electronic change management system. This article outlines five key ...

The Ultimate Guide to QMS Software

This QMS software guide outlines the key considerations to help you establish compliant quality management processes. ...

Training Record Management Software: The First 3 Steps to Automation

Training record management is a major element of quality management, compliance, and regulatory practices as well as employee ...

Validation for Cloud Software

When evaluating software vendors, be sure to prioritize validation. Multi-tenant cloud vendors give you a head start by doing IQ and OQ for you. Cloud...

How to Classify Your Medical Device for FDA Approval

The FDA classification process can be a daunting task. Where do you start and how do you know that your medical device is assigned the proper classifi...

The 5 Essential Elements of a CAPA System

Using a compliant quality management system (QMS) with a CAPA subsystem, your company will be ahead of the 465 companies with CAPA-related FDA 483s. ...

5 Tips to Pass Your FDA or ISO Audit with Confidence

An FDA or ISO audit is a necessary and potentially difficult part of doing business for any medical device manufacturer. For startup medical device ma...

What Are the Key Elements of a Quality Management System (QMS)?

Having an effective quality management system (QMS) in place for life sciences companies is critical to help organizations reach their product develop...