The New FDA 21 CFR Part 820 – Quality Management System Regulation
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1M ago
It has now been two months since the US Food and Drug Administration (FDA) published its final rule amending the Current Good Manufacturing Practice (CGMP) requirement of the Quality System Regulation (QSR) (21 CFR Part 820) to incorporate by reference, and thereby align more closely with, the international consensus standard ISO 13485:2016, Medical devices—Quality management systems—Requirements for regulatory purposes.  The new regulation, referred to as the Quality Management System Regulation, or QMSR for short, is the medical device industry’s latest significant regulatory change and ..read more
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US FDA recognition of Vaporized Hydrogen Peroxide sterilization as Established Category A method
BSI Compliance Navigator Blog
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3M ago
Over the past years, the US FDA has announced a number of initiatives, including Ethylene Oxide (EO) Innovation Challenges and Master File Pilot programs, to advance innovation and streamline the regulatory pre-market approval process. On 8 January 2024, the US FDA announced the re-issue of the guidance titled “Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile”, superseding its 2016 version. In this blog, we will explore what are the significant changes in the guidance; what prompted these changes; and what are the impl ..read more
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Appropriateness Use of Test for Sterility
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3M ago
Instances of misuse of the test for sterility are often encountered. The most common examples being the testing of expired medical devices to prove that the sterile shelf-life has been delivered; or the testing of products marked as sterile where there is some suspicion about a deficiency in the sterilisation process, or the packaging integrity, to determine whether the products can be used or not. Not only is this testing inappropriate for either of these purposes but it will also almost certainly lead to incorrect and misleading conclusions, perhaps even risking the very safety that such tes ..read more
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FDA and ISO 13485 – Cause for Concern or Celebration?
BSI Compliance Navigator Blog
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3M ago
After years of speculation by the medical device community, on 2 February 2024, the US Food and Drug Administration (FDA) published its final rule amending the current good manufacturing practice (CGMP) requirement of the Quality System Regulation (QSR) to incorporate by reference, and thereby align more closely with, the international consensus standard ISO 13485:2016, Medical devices—Quality management systems—Requirements for regulatory purposes. The new regulation is called the Quality Management System Regulation (QMSR) Final Rule and is the latest significant regulatory change affecting ..read more
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Embracing sustainability and the circular economy in the medical device industry: Understanding the differences
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5M ago
The medical device industry is immersed in innovation, consistently pushing the boundaries of what is possible in healthcare. Amidst these advancements, two essential concepts have emerged that are seen as both enablers and inhibitors to innovation: Sustainability and the circular economy. While often used interchangeably, they represent distinct approaches to addressing environmental, economic, and global supply chain challenges. In this blog, we will explore the key differences between sustainability and the circular economy in the medical device industry ..read more
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Regulation of Medical Devices and In Vitro Diagnostic Medical Devices in Northern Ireland
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6M ago
The regulation of medical devices and in vitro diagnostic (IVDs) medical devices in Northern Ireland is governed by the Windsor Framework. This means that the EU Medical Device Regulation ((MDR)(EU) 2017/745 and In Vitro Diagnostic Medical Device Regulation (IVDR) (EU) 2017/746 have applied in Northern Ireland in line with the respective dates of application across the EU. The Medicines and Healthcare Products Regulatory Authority (MHRA) is the de facto Competent Authority for Northern Ireland and has specific requirements for registration, vigilance reporting etc ..read more
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The Differences and Similarities between ISO 9001:2015 and ISO 13485:2016 | Part 2
BSI Compliance Navigator Blog
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9M ago
It has been more than 6 years now that ISO 9001 has been using the High-Level Structure (HLS) as outlined in the ISO/IEC Directive, Part 1. There have not been any significant problems created by the divergence of the two standards. In this update we will discuss the current activities by both Technical Committees and other activities by the ISO organization and others that could be of significance. While there are still many people that focus on the differences, it is clear that the standards continue to be used alongside each other without significant issues as there remains no direct confli ..read more
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The Differences and Similarities between ISO 9001:2015 and ISO 13485:2016 | Part 1
BSI Compliance Navigator Blog
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9M ago
It has been more than 6 years now that ISO 9001 has been using the High-Level Structure (HLS) as outlined in the ISO/IEC Directive, Part 1. There have not been any significant problems created by the divergence of the two standards. In this update we will discuss the current activities by both Technical Committees and other activities by the ISO organization and others that could be of significance. While there are still many people that focus on the differences, it is clear that the standards continue to be used alongside each other without significant issues as there remains no direct confli ..read more
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What is 60601 - all you need to know
BSI Compliance Navigator Blog
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10M ago
IEC 60601 refers to a series of international standards that pertain to the basic safety and essential performance of medical electrical equipment. These standards are issued by the International Electrotechnical Commission (IEC), a global organization that develops and publishes international standards for electrical, electronic, and related technologies and has been adopted by CENELEC without technical modification for use in Europe where it is designated EN 60601 ..read more
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Do you know what the requirements of the EN 60601 are
BSI Compliance Navigator Blog
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10M ago
EN 60601 specifies a set of requirements that medical electrical equipment and systems must meet to ensure safety and essential performance. The specific requirements vary depending on the part and edition of the standard. Below you can find an overview of the general categories of requirements covered by EN 60601 ..read more
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