The US FDA released its final rule on QMS, furthering global harmonization of regulatory requirements.
News and updates
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Have thoughts about ISO 13485? Share your feedback!
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Do you use ISO/TR 20416 for post-market surveillance? Tell us why or why not!
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Modifications to the title and scope statement for ISO/TC 210 have now gone into effect.
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ISO/TC 210 will host a workshop on post market surveillance on 14 December 2022.
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Most people see the term “risk” as an indication of something to be avoided. Like the risk of being mugged if you walk alone in the night in a dark alley. Or that your bicycle is stolen. For many product sectors, including the medical devices sector, there is a special meaning associated with the term “risk”. This meaning is included in many regulatory frameworks, typically combined with the requirement to minimize risk. Since some 15 years, ISO allowed an additional meaning to this term, causing a lot of confusion and irritation. This article aims to explain some of that.
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Recently, two ballots for committee resolutions were held - and approved - to change the scope text and title of ISO/TC 210.
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Arjan van Drongelen, former convenor of ISO/TC 210/WG6, received the ISO Certificate of Excellence for his efforts in driving the development and publication of ISO/TR 20416:2020, an ISO Technical Report on post-market surveillance (PMS) for manufacturers.
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The European standard EN ISO 14971:2019 with its amendment A11:2021 is finally cited in the Official Journal of the European Union (OJEU) as a harmonized standard.
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Longtime participant in ISO/TC 210 activities, Arjan van Drongelen, has changed jobs and consequently will no longer be engaged in standardization. He has provided a personal goodbye note to ISO/TC 210 members.
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On 28 September 2021, the JAG5 "Medical Device Life Cycle" had its kick-off meeting.
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As of October 2021, ISO/TC 210 has a new ISO Technical Programme Manager (TPM): Ms. Kirsi Silander.
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Sergio Mujica, ISO Secretary-General, has awarded Jeff Eggleston the ISO Excellence Award for his contributions as convener of ISO/TC 210 WG3.
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Reducing and managing risks related to medical devices is the objective of a key industry standard, ISO 14971. Detailed guidance to optimize its use has just been updated.
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The presentations are now available from the ISO/TC210 Risk Management Workshop that was conducted on 9 October 2019 in London.
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BSI and ISO/TC 210 jointly organize a workshop on risk management for medical devices. The main reason for this workshop is the imminent publication of the revised edition of ISO 14971 (“Medical devices - Application of risk management to medical devices”) and ISO/TR 24971, its companion document.
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The national members of ISO and IEC have approved for publication the third edition of ISO/IEC Guide 63, Guide to the development and inclusion of aspects of safety in International Standards for medical devices. A joint project of ISO/TC 210 and IEC/SC 62A, Guide 63 provides standards writers in the healthcare technology sector with practical guidance on how to include safety aspects when developing standards for the sector. This includes management system standards related to medical devices.
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ISO 13485 has been designated by ISO as a management system standard (MSS), more in particular a sector-specific MSS. The fact that ISO 13485 has been designated an MSS means, in principle, that if the standard is revised, it will have to adopt the high-level structure (HLS). This structure is known since 2012 as the ISO-HLS and is included in the ISO/IEC Directives as Annex SL (in the ISO supplement). Besides being mandatory for MSSs, it is more than just a structure for management system standards: it comes with some 10 pages of mandatory text. By the end of 2018, IEC decided to also adopt this HLS for standards within the IEC domain that also are (or can be considered) management system standards. With the publication of the 2019 edition of Part 1 of the ISO/IEC Directives, it is now available as Annex L.
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ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes workshop hosted by the Ministry of Food and Drug Safety (MFDS) and the National Institute of Medical Device Safety Information (NIDS) was held in Seoul Korea on November 13th, 2018.
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During the upcoming series of meeting for ISO/TC210, there will be a workshop with the professional committee on the status of ISO 13485:2016 and its future, which is the standard for medical device quality management systems.
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A survey designed to obtain stakeholder feedback on ISO 13485:2016 and the medical device sector’s experience in the transition is now open.
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ISO has recently posted the updated Strategic Business Plan (SBP) for ISO/TC 210 on their website. It is available for free to the public.
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A large majority of the voting members approved the 2018 Strategic Business Plan for ISO/TC 210, without a single negative vote!
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ISO has decided to recognize several experts within ISO/TC210 for their most notable and exemplary service to the committee and, with that, to society.
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Recent changes to the ISO Directives instruct TCs to update their SBP at least once every three years. At the plenary meeting of ISO/TC 210, in Japan, last October, it was announced that the revised SBP was nearing completion.
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Two key ISO/TC 210 standards have recently been harmonized in the European Union. The reference to EN ISO 13485:2016 and EN ISO 15223-1:2016 where both published in the Official Journal of the European Union on Friday, 17 November 2017.
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The long awaited ISO 13485:2016 Handbook has just been published by ISO!
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Working on ISO 13485:2016 for your organization? The long-awaited handbook for all stakeholders is almost here!
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Joint Working Group 1 (JWG1) between ISO/TC 210 and IEC/SC 62A had a fruitful meeting in June 2017 in Delft, The Netherlands. The main focus was on the revision of the risk management standard ISO 14971.
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The Strategic Business Plan, or SBP, of ISO/TC 210 is available on the ISO website, was last revised in 2015. With the recent publication of documents like ISO 13485, ISO 16142-1, ISO/TR 80002-2, and several parts in the series of ISO 18250 and ISO 80369, the SBP deserves to be updated.
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Joint Working Group 1 between ISO/TC 210 and IEC/SC 62A is preparing the next editions of ISO 14971 Medical devices – Application of risk management to medical devices and its companion document ISO/TR 24971 Medical devices – Guidance on the application of ISO 14971.
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Safety and quality are non-negotiables in the medical devices industry. Regulatory requirements are increasingly stringent throughout every step of a product’s life cycle, including service and delivery. More and more, organizations in the industry are expected to demonstrate their quality management processes and ensure best practice in everything they do.
ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry. It has recently been revised, with the new version published in March 2016.