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  • RF Quarterly

    RF Quarterly, October 2021: Quality and compliance

    Welcome to the fall issue of RF Quarterly in which international experts from the US, EU, and Saudi Arabia examine quality and compliance and their governing regulations, with specific focus on data integrity, quality system design and management, current good manufacturing practice (cGMP), and postmarketing activities in relation to medical devices, pharmaceuticals, and biologics.   Pragmatism, integrity, and QMS Data reliability in all formats and parts of an o...
  • RF Quarterly

    Medical device quality management systems

    Introduction A quality management system (QMS) is one of the five medical device conformity assessment elements. 1 Manufacturers of medical devices are expected to implement, document, and maintain a QMS that “ensures the medical devices it designs, manufactures, and supplies to the market are safe, perform as intended, and comply with the relevant provisions of the regulations in the countries where the product is made available.” 2   Today, a QMS is seen as a ...
  • RF Quarterly

    Enabling the digital transformation of industry: The roles of AI, big data, analytics, and related data ecosystem

    This article outlines the work of SC 42, the technical subcommittee for artificial intelligence (AI) of the ISO/IEC’s joint technical committee 1, which aims to accelerate adoption of the standards while simultaneously addressing emerging issues to enable successful digitalization of sectors.   Introduction and overview The digital transformation of industry promises to revolutionize how we live, work, and play, unlocking the vast potential of new use cases and ap...
  • Regulatory NewsRegulatory News

    Shuren updates on inspections, ISO 13485 and MDUFA V

    Long delayed — even before the COVID-19 pandemic — the US Food and Drug Administration’s (FDA) proposed rule to harmonize its medical device Quality System Regulation (QSR) with the international standard, ISO 13485:2016, may finally see the light of day this year.   The much-anticipated proposed rule has been on FDA’s regulatory agenda for several years, and despite COVID-related delays, it is back on track, Jeff Shuren, director of the Center for Devices and Radiolog...
  • Regulatory NewsRegulatory News

    FDA Modifies List of Standards for Premarket Device Reviews

    The modified list of standards published on Wednesday is meant to assist medical device manufacturers that elect to declare conformity with consensus standards to meet certain US Food and Drug Administration (FDA) requirements. Back in 1997, the Food and Drug Administration Modernization Act allowed FDA to recognize consensus standards developed by national and international organizations to satisfy certain portions of device premarket review submissions or other requ...
  • Regulatory NewsRegulatory News

    New Report Compares FDA Quality System Requirements With ISO 13485:2016

    The Association for the Advancement of Medical Instrumentation (AAMI) this week released a technical information report to help the medical device industry prepare for the revision of 21 CFR 820 (also known as the quality system regulation), which will harmonize with ISO 13485:2016 later this year. The most recent regulatory agenda says that sometime this month the US Food and Drug Administration (FDA) will issue a proposed rulemaking on the harmonization and moderniz...
  • Regulatory NewsRegulatory News

    Experts Tell Device Companies Not to Fret Over QMS Transition

    Ahead of the proposed shift away from the current US Food and Drug Administration (FDA) quality management system (QMS) CFR 21 Part 820 regulation toward ISO 13485:2016, a new white paper sheds light on how the action will impact medical device development. The white paper identified three interrelated principles that will define the direction of the agency’s process, which has yet to be clearly defined, after the transition . These principles relate to the concept of ...
  • Regulatory NewsRegulatory News

    Transition to ISO 13485:2016 Comes to an End

    The three-year transition period for ISO 13485:2016 officially ended Thursday and as of Friday all ISO 13485:2003 certificates are now null and void, regardless of their original expiration date. The role of the revised standard plays into major regulatory initiatives worldwide aimed at international harmonization. Both the 2003 and the 2016 version of the global consensus standard—developed by the International Organization for Standardization (ISO—co-existed until Thu...
  • Regulatory NewsRegulatory News

    US Regulatory Landscape for Medical Devices: A Year in Review and a Look Ahead

    From a transition to the global standard for quality management systems (QMS) to the revamping of premarket review pathways in the US, the medical device industry can expect to see at least some regulatory initiatives that 2018 set in motion come to fruition in 2019.   The Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA) has released  its list of guidances, indicating which topics will take precedence for 2019 policy cla...
  • Regulatory NewsRegulatory News

    Health Canada Drafts Policies on 3D-Printed Implantable Devices

    Health Canada released draft guidance Thursday to aid manufacturers in preparing license applications for implantable medical devices produced by additive manufacturing or 3D-printing.   The guidance “represents the first phase of 3D-printing policy in Canada” because Health Canada intends to continuously adapt its policies to emerging issues on the topic “due to the fast-changing technological environment,” the regulator said.   3D-printed medical devices may be s...
  • Regulatory NewsRegulatory News

    Insights on Upcoming Revisions to ISO 13485

    Following the new outcome meeting statement posted Monday by the management committee of the International Medical Device Regulators Forum (IMDRF), Focus obtained insights into upcoming revisions to the global standard for quality management systems (QMS), ISO 13485.   The outcome statement from the September IMDRF meeting in Beijing, China points to a decision made by the management committee to issue a position statement to the International Organization for Standa...
  • Feature ArticlesFeature Articles

    Identification of Medicinal Products (IDMP) Standards Part 2: The Implementation Roadmap

    This is part two of a series on the Identification of Medicinal Products (IDMP) standards and their respective implementation guidelines. 1-9 Part two reports on current IDMP activities and provides the plans and timelines in the IDMP implementation process. Part one 10 presented the reasons for the new standard, the driving forces behind IDMP and the concepts behind the standard. Current Status of ISO Activities A new version of the International Organization for...