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  • 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...
  • Regulatory NewsRegulatory News

    How Will ISO 13485:2016 Impact Your Relationship With Suppliers?

    • 22 November 2016
    • By
    This article covers how the new ISO 13485 standard 1 affects risk management for suppliers. The 2016 revision to ISO 13485 may have profound implications for the medical device industry. The updated standard will alter the way device makers interact with suppliers, from supplier selection to the management of supplier relationships. What the new Standard Says About Risk One particularly notable change with ISO 13485:2016 2 is the addition of more explicit ris...
  • Feature ArticlesFeature Articles

    How Will ISO 13485:2016 Impact Your Relationship With Suppliers?

    This article covers how the new ISO 13485 standard 1 affects risk management for suppliers. The 2016 revision to ISO 13485 may have profound implications for the medical device industry. The updated standard will alter the way device makers interact with suppliers, from supplier selection to the management of supplier relationships. What the new Standard Says About Risk One particularly notable change with ISO 13485:2016 2 is the addition of more explicit ris...
  • Regulatory NewsRegulatory News

    ISO 13485: Ex-FDA Official Kim Trautman Gives Advice on Transitioning

    Speaking at RAPS' 2016 Regulatory Convergence, leading medical device quality systems expert and former FDA official, Kim Trautman, urged attendees to begin their transition to the recently released ISO 13485:2016 as soon as possible. Trautman, who left her position as associate director for international affairs at FDA's Center for Devices and Radiological Health (CDRH) for a position at NSF International earlier this year, was instrumental in writing FDA's 1996 Quality...
  • Regulatory NewsRegulatory News

    New ISO 13485: Device Companies Have Three Years to Transition

    The International Organization for Standardization (ISO) late last month released its long-awaited revision to ISO 13485, the global standard for medical device quality management systems (QMS), which replaces the previous version from 2003. The new revision places a greater emphasis on QMS throughout the supply chain and product lifecycle, as well as device usability and postmarket surveillance requirements. Over the next three years, ISO 13485:2003 and ISO 13485:2016 ...
  • Regulatory NewsRegulatory News

    FDA Ends Voluntary Audit Pilot Ahead of 'Fully Operational' MDSAP

    The US Food and Drug Administration (FDA) says it is discontinuing one of its audit-sharing pilots ahead of the launch of a "fully operational" Medical Device Single Audit Program (MDSAP) in 2017. FDA announced the changes in the Federal Register on Thursday, saying it "will no longer accept ISO 13485:2003 Voluntary Audit Report Submissions after March 31, 2016, to assist transitioning manufacturers over to MDSAP." ISO 13485:2003 Submission Pilot In 2010, FDA released ...
  • Regulatory NewsRegulatory News

    India Seeks Input on Draft Revisions to Device GMPs

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. India’s Central Drugs Standard Control Organization (CDSCO) is seeking input on draft revisions to Schedule M-III of the country’s Drug and Cosmetic Act , which describes good manufacturing practices (GMPs) for medical devices. The revisions aim to bring the GMP requi...