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QMS Compliance

Thinking about selling your medical device in Brazil? If so, you should know that the Brazilian medical device and IVD market is complex. The changing legislative landscape combined with the limited resources at the Brazilian Health Surveillance Agency (ANVISA) often cause frustration for domestic and foreign manufacturers. But if you are willing to put in the effort, the Brazilian market has potential. In this 9-page white paper, we'll answer your biggest questions about regulatory requirements for medical device manufacturers in Brazil, including: What is Brazilian medical device/IVD GMP?...
The new ISO 13485 revision is finally here and, for medical device manufacturers, this is big news. You probably have plenty of questions about how the new standard will affect your company: do I have to completely overhaul my QMS? When do I have to comply? ISO 13485:2016 provides an international standard that can be truly harmonized across multiple regions and regulatory requirements. But it also introduces notable QMS changes, particularly in the area of risk management. In this 16-page white paper, we answer your biggest questions about ISO 13485:2016, including: Overview of the update to...
Biocompatibility testing: an intimidating, time-consuming, and, at times, very expensive requirement in most major medical device markets. Biocompatibility testing is the systematic evaluation of a product's biological safety to avoid any risk of bio-incompatibility with the human body. If you are marketing a device in Europe, the US, or even beyond, the ISO 10993 series is your guide to biocompatibility testing requirements. It provides guidelines and requirements for manufacturers to appropriately mitigate the biological risks up to and including testing to confirm biocompatibility. In this...
Are you ready to sell your medical device in the United States? If so, your company must comply with the US FDA Quality System Regulation (QSR), specifically known as 21 CFR Part 820. Even if you already have a quality management system in place, such as ISO 13485, your quality system must meet this regulation before you can sell your device. In this video, we’ll take a look at 21 CFR Part 820 and what the regulation entails. We’ll discuss: An overview of 21 CFR Part 820 Key players in the QSR implementation process Examine important sections of QSR What it takes to maintain compliance You’ll...
Are you marketing a wireless, networked, or interconnected medical device in the United States? If so, you can expect intense regulatory scrutiny from the US Food and Drug Administration (FDA). The FDA pays special attention to cybersecurity vulnerabililties in medical devices, and has established cybersecurity control requirements for network, wireless, and similar technologies. Manufacturers must take extra measures to ensure the cybersecurity of their device throughout its lifecycle. In this white paper, we address your biggest questions about US regulatory requirements for wireless...
Are you ready for a random audit by the FDA? If you are lucky, you might only have a few weeks or even days to get ready for a visit from the FDA. When this happens, your quality system should be well maintained and compliant with 21 CFR Part 820. But, there are things you can do to ensure your FDA inspection goes smoothly. In this video, we discuss what to do (and what not to do) before, during, and after an FDA audit, including: what to do immediately after the audit is scheduled how to prepare your facility for the inspector who should interact with the inspector when to prepare and...
Interested in selling your medical device in the United States? If the answer is yes, the US Food and Drug Administration requires you to comply with its Quality System Regulation (QSR) outlined in 21 CFR Part 820. FDA QSR implementation can be a daunting task, especially for start-up medical device companies. In this free whitepaper, we provide a high-level overview of 21 CFR Part 820 and answer your biggest questions about the implementation process, including: Who needs to comply with FDA QSR 21 CFR Part 820? What are the key elements of the FDA QSR? What are the phases of the...