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standards

Standards

FDA has created a webpage dedicated to regulation of Medical Device Data Systems. Note that the deadline for registration and listing (including for healthcare institutions that would be considered MDDS manufacturers) is May 18, 2011, and the deadline for reporting adverse events through MedWatch is April 18, 2012.
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The new work item proposal (NWIP) for a standard for “Healthcare Software Systems – Part 1: General requirements” was approved in IEC. 82304-1 62A 839 CD
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A proposal for a guidance document on “Applying the Quality System to Medical Device Data Systems” has been submitted to AAMI by the FDA. The work is expected to be done by the AAMI software committee and the AAMI Quality Management committee.
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There is a specific standard for radiotherapy treatment planning systems, IEC 62083 Edition 2.0 (2009-09-23) Medical electrical equipment – Requirements for the safety of radiotherapy treatment planning systems. When there is a specific standard, it takes precedent over general standards. IEC 60601-1 only applies to medical electrical equipment. So software that is a stand alone...
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IEC 60601-1 only applies to medical electrical equipment. So software that is a stand alone product does not fall within the scope of IEC 60601-1. A new work item on Healthcare Software Systems was recently approved. This new standard is intended to apply to stand alone software and will have similar (but not necessarily the...
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The AAMI Human Factors committee has proposed a work item to develop a new standard: “AAMI/HE N245R2, Human factors engineering design processes for medical device software not considered a medical device”.The current proposal is the scope would be Heath IT user interface engineering for software not considered part of a medical device.
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This content is only available to Standards Navigator subscribers.  See our Subscribe page for information on subscriptions. A new work item and draft technical report for guidance in implementing IEC 80001-1:2010. This TR provides practical guidance for doing risk management for hospital networks.The report is at the link provided until the review period ends on 24-Feb-2011. IEC...
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This content is only available to Standards Navigator subscribers.  See our Subscribe page for information on subscriptions. A new work item and draft technical report for guidance in implementing IEC 80001-1:2010. This TR provides a framework for a dialogue between a medical device manufacturer and a hospital regarding system and data security controls. The report is at...
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This website provides access to the latest lists of references of harmonised standards and other European standards. “Manufacturers, other economic operators, or conformity assessment bodies can use harmonised standards to demonstrate that products, services, or processes comply with relevant EU legislation.”
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http://www.fda.gov/downloads/aboutfda/reportsmanualsforms/forms/ucm081667.pdf
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http://www.massdevice.com/blogs/massdevice/medical-devices-next-hackers-target-list
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CDRH is immediately recognizing IEC 60601-1, third edition. The announcement was made yesterday morning at the 20th annual AAMI/FDA international standards conference by Carol Herman, director of the standards management staff at CDRH. The center’s acceptance of the standard also includes “all collaterals and particulars,” said Herman. She anticipates CDRH will publish a Federal Register...
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The European Commission Borderline and Classification committee has put out a call for software experts to join a working group on qualification and classification of software. The first meeting will be December 2nd, and will be chaired by Lennart Philipson from the Swedish Medical Products Agency. The Medical Information System report from Sweden has been...
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The EU standardization organizations, CEN and CENELEC, have formed a joint working group on standards for software and medical devices (SAMD). The first meeting will be December 8th. Notice is at the link provided. With the harmonization of IEC 62304 (including for IVD devices), potential modifications to the scope of 60601, and the recent Medical...
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/docs/FDATraining-Module7IEC62304-BECSconferencePresentation-JMurray110409.pdf
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CDRH moved to a new location. The address of the document mail center for submissions and related communications is now: U.S. Food and Drug Administration Center for Devices and Radiological Health Document Mail Center – WO66-G609 10903 New Hampshire Avenue Silver Spring, MD 20993-0002
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“IEC TR 80002-1 Medical device software – Part 1: Guidance on the application of ISO 14971 to medical device software” has been released. This standard was based on AAMI TIR32 but focuses on the 14971 perspective. AAMI has adopted TR 80002-1 as well and may obsolete TIR32 although there are some areas where TIR32 is...
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These two draft standards for networked medical devices and for medical device software risk management have been renumbered IEC 80001-1 and IEC 80002-1 respectively. IEC 80002-1 was released for a 3 month ballot period Jan 16, 2009.
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The pdf at the link provided is a reprint of an article entitled An Introduction to IEC 80001: Aiming for Patient Safety in the Networked Healthcare Environment” authored by Sherman Eagles, Partner at SoftwareCPR. This is reprinted with permission from the Association for the Advancement of Medical Instrumentation (AAMI), www.aami.org. The article first appeared in...
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IEC 62304 and IEC 60601-1 3rd edition were harmonized in the European Union on November 28. A claim of compliance with 62304 now provides a presumption of conformity with the MDD and AIMDD for software. In addition, 62366 – application of usability engineering to medical devices has also been harmonized.
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IEC/CD2 80001, Application of risk management for IT-networks incorporating medical devices was released for balloting on 11/25/2008 by AAMI. This standard applies to Medical Device manufacturers as well as healthcare IT organizations. The deadline for comments is Jan 15, 2009. An article about this standard by SoftwareCPR partner Sherman Eagles is posted on this website.
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The Chinese regulatory authority SFDA has adapted IEC 62304 “Medical device software – software lifecycle processes” as the software development standard for the Chinese Medical Device Industry. It has been translated to chinese. The publishing date is April, 25, 2008. The implementation date is June 1, 2009.
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The 1998 2nd edition of the standard UL 1998 Software in ProgrammableComponents was reaffirmed and reissued Oct 28, 2008. There were no substantive changes. This is one of the few software standards recognized by FDA.
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https://www.softwarecpr.com/Docs/JohnMurraySlides-IEC62304-091508.pdf
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CENELEC decides to include 62304 harmonization for the IVD directive based on a recommendation of TC 62. This is in addition to the MDD and AIMD.
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The new revision of ISO 14971 was released in 2007 and is now a harmonized standard in the EU. The transition period for companies using the previous version ends March 9, 2010.
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The draft AAMI Technical Information Report “Validation of software for regulated processes” has completed balloting. This document addresses software used to automate production and quality systems. The working group is resolving comments submitted and the timeline for release is Q1 2008.
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The new version of IEC 60601-1 (3rd edition, 2005) replaces IEC 60601-1-4, not just ISO 14971. IEC 60601-1-4 includes both risk management requirements and PEMS development process requirements. IEC 60601-1-4 remains a harmonized standard in the EU to meet the essential requirement of the MDD on PEMS, if the 2nd edition of IEC 60601-1 is...
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The EU parliament reviewed the suggested changes to the Medical Device Directives including software related changes. The full Oct 2006 report is at the link provided. MDD
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IEC 62A and ISO 210 balloting is complete and both approved the work item to initiate project number IEC 80002 Medical device software – Guidance on the application of ISO 14971 to medical device software. The first working group meeting will be in May in Germany. Depending on the direction this work takes it could...
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Sherman Eagles, a Medtronic Standards representative and co-chair of the AAMI software committee, gave a presentation on changes and new developments in software standards at the Nov 2006 Advamed conference. This presentation is at the link provided. It addresses the withdrawal of ISO/IEC 60601-1-4 and the incorporation of Programmable Electronic Medical Systems (PEMS) into the...
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A new work item proposal was approved to begin a draft Risk Management of IT networks incorporating medical devices. Formal work is planned to beginning in January 2007.
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http://webstore.iec.ch/webstore/webstore.nsf/$$search?openform
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http://www.fda.gov/cdrh/oivd/presentations/042004-callaghan-software.html#footnote_2
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The EU issued proposed new text for the Medical Device Directive (MDD). The document with highlighted revisions, additions, and deletions is at the link provided. The proposed changes include several additions to more explicity address software. These include adding: the word “software” into the definition of a medical device in section 2(a) Annex I 12.1b...
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The EU issued a proposal to modify the MDD. This proposal expresses several suggestions related to software. The full text is at the link provided. EU proposal for revision of MDD
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AAMI Standards Conference Software Session 2005 including 4 FDA presentations The following are all included in the pdf at the following link: AAMI Standards Conference Software Session 2005 Review of Software in Premarket Submissions (new guidance for CDRH and CBER) – David S. Buckles FDA CDRH ODE Cybersecurity for Networked Medical Device Containing (OTS) Off-the-Shelf Software...
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The following question was asked during the “Ask the FDA” session (326-QE) on 10/25/04 at the AABB Annual Meeting held in Baltimore, MD as reported by SoftwareCPR Partner Molly Ray: When blood establishment computer software manufacturers distribute their device (software) for beta testing, they are required to label the software in accordance with the IDE...
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A final ballot version of the AAMI Software Risk Management Technical Information Report was issued to the AAMI Software Committee. Balloting will end on Sept. 24, 2004. Members of the committee can obtain a copy directly from AAMI.
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This is one of the FDA recognized software standards.
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IEC 62304 and other emerging standards for Medical Device and HealthIT Software

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Being Agile & Yet Compliant (Public or Private)

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2-days onsite with group exercises, quizzes, examples, Q&A.

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