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QMS Compliance

The new ISO 13485:2016 quality management system standard for medical devices introduces lots of new changes and concepts. However, its emphasis on risk management and a risk-based approach has many device companies wondering exactly what they need to do to meet the expectations of Notified Bodies. As the deadline to recertify approaches, a clear understanding of the standard's risk requirements is critical. In this white paper, we detail the changes required by the standard along with some suggested updates in regards to the risk-based approach. We'll answer your biggest questions about risk...
The publication of ISO 13485:2016 introduced significant changes for device manufacturers around the world. Some changes are specific, while others relate to the overall approach to quality management systems for device companies. After watching this video, you will have a better understanding of the most significant changes in the new standard, including how the changes will affect: executive management data, design, and other controls your suppliers your employees You'll also learn when you need to recertify to the new standard and how to plan your transition.
Register for our free webinar on Transitioning to ISO 13485:2016
ISO 13485:2016 is the first major revision to the global quality system standard since 2003. In this one hour recorded webinar we cover the major changes that have been made and tell you what needs to be done before you seek recertification by your Notified Body. Topics: Timeline for certification transition for current certificate holders and new ISO 13485 certifications Comparison with other management standards and global regulatory expectations Brief overview of the significant changes made between the 2003 and 2016 versions Review of emphasized areas for the quality system that are...
Register for our free webinar on Risk Management changes in ISO 13485:2016
Risk management requirements for medical device manufacturers will expand significantly with the publication of ISO 13485:2016. Manufacturers will have to approach risk management controls in a new way, and change how they integrate it with their quality management system procedures. In this recorded webinar we discuss risk management practices for global device manufacturers and how these rules will change. TOPICS COVERED High level summary of current medical device manufacturer risk management requirements Common deficiencies in risk management processes Types of risks applicable to medical...
In November 2014, Japan introduced the Pharmaceutical and Medical Device Act (PMD Act), which made significant changes to the country's medical device registration process. It also changed the way manufacturers meet quality management system requirements. While Japan's quality regulations are similar to ISO 13485, there are some important differences you should be aware of if you want to sell your medical device in Japan. In this white paper produced by Emergo's office in Tokyo, we answer your biggest questions about QMS requirements in Japan, including: Who is an applicant for QMS Conformity...
This white paper will discuss the requirements for achieving compliance with the Quality Management System (QMS) regulations as they apply in Canada for obtaining a Medical Device License (MDL) under the Canadian Medical Devices Conformity Assessment System (CMDCAS).
Are you prepared for a random FDA audit? The United States Food and Drug Administration often announces their plans to audit your company at the last minute. With only a few days’ notice, what should you do first to prepare for an FDA inspection? And what can you expect once the investigator arrives? FDA QSR inspections don’t have to be as dramatic as they sound. Preparation, planning, and clear expectations will make your next FDA audit less stressful, and you might even pass with flying colors. This paper describes exactly what to expect from an FDA audit and how to prepare for the...