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Company: Visx Incorporated Date of Enforcement Report 8/27/2008 Class:ll PRODUCT Excimer Laser System; WaveScan WaveFront System, Software Version 3.65, for use with the VISX STAR S4 and STAR S4 IR Excimer Laser Systems. System is a diagnostic instrument intended for the automated measurement; analysis and recording of refractive errors and wavefront aberrations to the target...
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Company:Siemens Medical Solutions USA. Date of Enforcement Report 8/27/2008 Class:ll PRODUCT Medical charged-particle radiation therapy system. Siemens Linear Medical Accelerators equipped with COHERENCE Therapist R2.0 and Oncologist R2.0. Product update, TH 030//07/S. The COHERENCE Therapist R2.0 software numbers are: 7358299, 7360857, and 8141835 and applies only to those parts used with the following devices: Coherence...
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Company: Impac Medical Systems Inc. Date of Enforcement Report 8/20/2008 Class:ll PRODUCT SEQUENCER, MOSAIQ versions 1.3 and 1.4 with Elekta and Siemens Machines, Model number 40003-001000-RO. Used to facilitate the delivery of defined radiotherapy treatment plans; Recall # Z-1515-2008 REASON Software issue may result in change to intended treatment field, Potentially resulting in mistreatment. RECALLING...
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Company: Sunquest Information Systems, Inc Date of Enforcement Report 8/20/2008 Class:ll PRODUCT Sunquest Laboratory Blood Bank and Blood Donor Modules v6.0.1, v6.0.2 and v6.4.0 (Beta) Distributed with Sunquest Laboratory v6.1, v6.2, v6.3 and v6.3.1 (Beta); Recall # B-1740-08 REASON Software, with a glitch or defect, was distributed RECALLING FIRM/MANUFACTURER Sunquest Information Systems, Inc., Tucson AZ,...
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Company: BD Biosciences Date of Enforcement Report 8/20/2008 Class:ll PRODUCT FACSDiva Software Versions 4.0.1 to 5.0.2, Flow Cytometry Acquisition & Analysis software. Catalog number 641609 Flexible data acquisition and analysis package specifically designed for digital-based flow cytometers; Recall # Z-1525-2008 REASON When data file containing one or no fluoresence parameters is exported, the software will...
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Company: Roche Diagnostics Corp/Hitachi Ltd Date of Enforcement Report 8/20/2008 Class:ll PRODUCT a) Roche/Hitachi Modular Analytics System, Modular D2400 Module GMMI clinical chemistry analyzer; Catalog number 04998618001. Intended for qualitative and quantitative in vitro determinations using a wide variety of tests; Z-0866-2008; b) Roche/Hitachi Modular Analytics System, Modular P800 Module GMMI clinical chemistry analyzer; Catalog...
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Company: Varian Medical Systems Oncology Systems Date of Enforcement Report 8/20/2008 Class:ll PRODUCT Varian Medical Systems On-Board Imager, Versions 1.0.15 and 1.2.05 Imaging Accessory to Medical Linear Accelerator. The On-Board Imager Device is used for verification of correct patient position in relation to isocenter and verification of the treatment fields in relation to anatomical and/or...
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Recipient: GE Healthcare Integrated IT Solutions Product: Centricity Imaging and other Picture Archiving and Communication System (PACS) products Date: 8/12/2008 1. Failure to establish and maintain adequate procedures for analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential...
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Company: BD Biosciences Date of Enforcement Report 8/13/2008 Class:ll PRODUCT BD FACSDiva Software v6.0 and 6.1 with the HP XW4400 Computer System Model/Catalog number 642685 Software is used to simplify acquisition of flow cytometry data, Recall # Z-1530-2008 REASON Values might not update in statistics views after certain functions are performed in a worksheet. RECALLING...
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Company: Beckman Coulter Inc Date of Enforcement Report 8/13/2008 Class:ll PRODUCT Cytomics FC 500 Flow Cytometry System with Data Innovations Instrument Manager, Part Numbers 626553 and 6605628 A system for the qualitative and quantitative measurement of biological and physical properties of cells and other particles, Recall # Z-1529-2008 REASON Labeling provided by two integrated software...
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Company: Hospira, Inc Date of Enforcement Report 8/13/2008 Class:ll PRODUCT Hospira LifeCare PCA Label Utility, Version 1.0 CD. The installation/user guide is entitled “LifeCare PCA Barcode Label Utility Program.” This software program is designed to allow entry of each drug concentration into a formulation library on a pharmacy computer for standardized printing of barcode labels...
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With the permission of Oliver Christ of PROSYSTEM AG in Hamburg, Germany, you can view or download slides at the link provided entitled: Cost-effective Application of Usability Engineering and Risk-Management. Oliver and his partner are heavily involved in standards and these slides provide an excellent overview of medical device usability, software, and risk management standards...
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http://edocket.access.gpo.gov/2008/pdf/E8-17739.pdf
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This SoftwareCPR.com newsletter lists items added to the web site since March 21,2008 and as of August 6, 2008 . It serves as an easy reference to find new or updated items that may be of interest to you and provides a full index of SoftwareCPR educational items. You can click on sections of the...
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Company: Sunquest Information Systems, Inc., Date of Enforcement Report 8/6/2008 Class:ll PRODUCT Sunquest Laboratory Blood Bank and Blood Donor Modules v5.2, Distributed with Sunquest Laboratory v5.3 and v5.4. and Sunquest Laboratory Blood Bank and Blood Donor Modules v6.0.1, v6.0.2 and v6.4.0 (Beta), Distributed with Sunquest Laboratory v6.1, v6.2, v6.3 and v6.3.1 (Beta), Recall # B-1137-08...
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Company: Biotronik, Inc Date of Enforcement Report 8/6/2008 Class:lll PRODUCT Lumax Cardiac Resyncronization Therapy Defibrillator (CRT-D); Implantable, dual-chamber defibrillator; Model Number: HF-T; Catalog Number 355263; Software Version 603.U; Catalog Model Number 359251; ICS 3000 units are composed of three Catalog/Model Numbers: 349527, 349530, and 355547. The model 349530 is the component which is loaded/updated with...
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Company: Varian Oncology Date of Enforcement Report 8/6/2008 Class:ll PRODUCT High-Definition 120 MultiLeaf Collimator, Medical charged-particle radiation therapy system; Software Version 7.0; Product Code: H56; Accessory to Medical Linear Accelerator, Recall # Z-1459-2008 REASON Dose Calculation Error: Software anomaly may result in failure of a MLC leaf to reach planned position, potentially resulting in misadministration...
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Company: GE Healthcare Integrated IT Solutions Date of Enforcement Report 7/23/2008 Class:ll PRODUCT GE Healthcare Centricity Perinatal (formerly QS) System – PFILS (Patient File Server) software; automatic patient data management providing clinical information at the bedside in Labor & Delivery, Mother-Baby and the Neonatal Intensive Care Unit, Recall # Z-2037-2008 REASON Patient information mix-up: When...
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Company: Beckman Coulter Inc. Date of Enforcement Report 7/30/2008 Class:ll PRODUCT a) Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 – FC 500 with UPS, Automated differential cell counter; Part Number: 626553; Recall # Z-2016-2008; b) Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 –...
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Company: Hitachi Medical Corporation Date of Enforcement Report 7/30/2008 Class:lll PRODUCT EUB-5500 VISION 5500 Diagnostic Ultrasound Scanner w/Step 5 (V05-7) Software. Imaging device intended to provide the physician with physiological and clinical information, Recall # Z-1571-2008 REASON Miscalculation reading. A software error in the firm’s EUB-5500/HI VISION diagnostic scanning system causes a miscalculation of the...
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Company: AGFA Corp Date of Enforcement Report 7/9/2008 Class:ll PRODUCT Impax 4.5, Impax 5.0, Impax 5.2 and Impax 5.2x Picture Archiving Systems (PACs) with integrated Voxar 3D software; and Impax 5.0 and Impax 5.2 PACs with integrated MediCAD software. The softwares are used to provide digital X-ray images for pre-surgical orthopedic planning, Z-1307-2008 REASON Misidentification:...
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Company: Zoll Medical Date of Enforcement Report 7/2/2008 Class:ll PRODUCT Zoll E Series Defibrillator with 12 Lead ECG, Automated external defibrillator, Software Version 3.00 and higher, Recall # Z-1167-2008 REASON Incorrect Patient Records: Patient records that have been stored, then later transmitted or printed may not be the correct record. Records that are transmitted or...
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Company: AGFA Corp Date of Enforcement Report 7/2/2008 Class:ll PRODUCT Agfa HeartLab Cardiovascular DICOMstore, Model # L9M8E. The software is used in the Agfa HeartLab Cardiovascular System, Recall # Z-1241-2008 REASON Misidentification: The electrocardiogram (ECG) data of one patient is misidentified as the data of another patient. RECALLING FIRM/MANUFACTURER Recalling Firm: AGFA Corp., Greenville, SC,...
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Company: GE Healthcare Clinical Systems Date of Enforcement Report 6/18/2008 Class:ll PRODUCT GE LOGIQ 3 Expert ultrasound scanner with software versions 4.0.5, 4.1.1 and 4.1.2, Recall # Z-1155-2008 REASON Inaccurate guidelines: The BE9C is an optional, small radius Bi-planar convex probe intended for use with the LOGIQ 3 Expert system in Urology application. An attempt...
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Company: Beckman Coulter Inc Date of Enforcement Report 5/28/2008 Class:ll PRODUCT a) Synchron LX20 Clinical Chemistry System, Part Numbers: 466200,473032, Recall # Z-1094-2008; b) Synchron LX20 PRO, Part Number 476100, Recall # Z-1095-2008; c) Synchron LXi 725, Part Number A08357, Recall # Z-1096-2008; d) UniCel DxC 600 Part Number: A10405, Recall # Z-1097-2008; e) UniCel...
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Company: Sunquest Information Systems, Inc Date of Enforcement Report 5/21/2008 Class:ll PRODUCT Sunquest Laboratory Blood Bank and Blood Donor, version 6.0.1 and 6.0.2, Recall # B-1337-08 REASON Software, with a glitch or defect, was distributed. RECALLING FIRM/MANUFACTURER Sunquest Information Systems, Inc., Tucson, AZ, by e-mail on March 26, 2008. Firm initiated recall is ongoing. VOLUME...
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Company: Siemens Medical Solutions, Inc., Date of Enforcement Report 5/21/2008 Class:lll PRODUCT Syngo US Workplace Picture Archiving and Communication System, software version 2.0, 94043. Material number: 10035829, Recall # Z-1138-2008 REASON Inaccurate results: A software bug may cause inaccurate wall motion abnormality scoring results to be displayed. RECALLING FIRM/MANUFACTURER Siemens Medical Solutions, Inc., Mountain View,...
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Company: Philips Healthcare Informatics, Inc., Date of Enforcement Report 5/14/2008 Class:lll PRODUCT iSite PACS image management system; Picture Archiving and Communications System; Radiology software package, Recall # Z-1141-2008 REASON Incorrect display of one of the patient’s images. This malfunction could cause an image to be incorrectly displayed, for example flipped left to right and anterior...
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Company: Siemens Medical Solutions, USA, Inc Date of Enforcement Report 5/7/2008 Class:ll PRODUCT a) Siemens Coherence AG Therapist, Part No: 5863506, medical charged-particle radiation therapy system with software version 2.1, Recall # Z-0971-2008; b) Siemens Coherence Therapist system, Part No: 7339125, medical charged-particle radiation therapy system with software version 2.1, Recall # Z-0972-2008; c) Siemens...
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Company: Beckman Coulter, Inc Date of Enforcement Report 5/7/2008 Class:lll PRODUCT a) Cytomics FC 500 MPL Flow Cytometry System with MXP Software, Software Version 2.1, Automated differential cell counter, Part Number: 626554, Recall # Z-0958-2008; b) Cytomics FC 500 MPL Flow Cytometry System with CXP Software, Software Version 2.2, Automated differential cell counter, Part Number...
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Company: GE Healthcare Integrated IT Solutions Date of Enforcement Report 5/7/2008 Class:ll PRODUCT GE Centricity PACS RA1000 Workstation; for diagnostic image analysis, Recall # Z-1104-2008 REASON Report missing characters: Four special characters, when entered into the exam notes, are not transferred to the preview panel or hard copy printout (greater than [>], less than [
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Company: Siemens Medical Solutions USA, Inc., Date of Enforcement Report 5/7/2008 Class:ll PRODUCT Leonardo Workstation Picture Archiving and Communication System, Model Number: 7129534, Software Version: VB30B, Recall # Z-1038-2008 REASON Incorrect display: The orientation labels will be incorrectly displayed on the reconstructed InSpace 3-D image if the orientation was not originally HFS on the acquisition...
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Company: ACUSON Sequoia Diagnostic Ultrasound System Date of Enforcement Report 4/30/2008 Class:ll PRODUCT ACUSON Sequoia Diagnostic Ultrasound System, general purpose Diagnostic Ultrasound system, a) Material Number 8245875; b) Material Number 8246951; c) Material Number 8267697; Recall Z-0661-2008 REASON Measurement Error affecting all Sequoia systems using the PAL video standard configuration and have a perspective PC...
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Recipient: Polymer Technology Systems, Inc.Product: CardioChek meters Date: 4/23/2008 The inspection revealed that the devices are adulterated under section 501(h) of the Act, 21 U.S.C. 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformance with the Current Good Manufacturing Practice...
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Company: BioRad BioPlex 2200 Software Date of Enforcement Report 4/23/2008 Class:ll PRODUCT BioRad BioPlex 2200 Software, for BioPlex 2200 Instrument, an automated immunodiagnostic analyzer, Recall # Z-0575-2008 REASON Incorrect values: An error was found in the BioPlex 2200 Software, Version 2.0 that results in assignment values being utilized for the BioPlex assay Calibrator Set that...
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Company: LifeScan OneTouch Data Management Software Version 1.0 Date of Enforcement Report 4/16/2008 Class:lll PRODUCT LifeScan OneTouch Data Management Software Version 1.0, Part Number: 021-722-01(for OneTouch Select and UltraMini (Download) Blood Glucose Meters), Recall # Z-1317-2008 REASON Meter Temporarily Freezes– A software compatibility issue may cause the blood glucose meter to cease operations and freeze...
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Recipient:iScreen, LLCProduct: Class II ophthalmic camera Date: 10/2/2007 This inspection revealed your ophthalmic cameras are adulterated within the meaning of Section 501(h) of the Act [21 USC 351(h)], in the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing...
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Company: Siemens Medical Solutions Date of Enforcement Report 4/9/2008 Class:ll PRODUCT a) Mevatron M2/PRIMUS MID Medical Linear Accelerator, Material Number: 019490035, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Recall # Z-1394-2008; b) Mevatron KD2 Medical Linear Accelerator, Material Number: 01940753, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Recall #...
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Company: Ventana Image Analysis System (VIAS), Date of Enforcement Report 3/26/2008 Class:ll PRODUCT Ventana Image Analysis System (VIAS) – PATHWAY anti-HER-2/neu (4B5) primary antibody with software version 2.3.0.2, Model Number: VIAS-799-10000-00, Pathology Image Analysis System, Recall # Z-0571-2008 REASON Incomplete upgrade: The software upgrade from February 1, 2007 may not have been completed. This software...
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This SoftwareCPR.com newsletter lists items added to the website from October 16, 2007 to March 21,2008. It serves as an easy reference to find new or updated items that may be of interest to you and provides a full index of SoftwareCPR educational items. You can click on sections of the document and the related...
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/docs/JMurrayFDAsoftwarecompliancesciencepresentationversion2.0-02-20-2008.pdf
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Company: BD Biosciences, Date of Enforcement Report 3/12/2008 Class:ll PRODUCT BD Biosciences MultiSET Flow Cytometry Software Versions 2.1, 2.1.1, and 2.2 with OS X operating systems, Recall # Z-0570-2008 REASON Inaccurate results: Software error results in inaccurate display result statistics. If the user adjusts the lymph gate or attractors in the Lab Report view without...
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Company: Roche Diagnostics Corp Date of Enforcement Report 3/12/2008 Class:ll PRODUCT Roche COBAS 6000 Clinical Chemistry analyzer; Catalog Number: 04745914001, Recall # Z-0576-2008 REASON Incorrect results: CRP assays may be calculated using incorrect calibration parameters which could result in falsely high or falsely low patient results being reported. RECALLING FIRM/MANUFACTURER Recalling Firm: Roche Diagnostics Corp.,...
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Company: Siemans- ACUSON Aspen Diagnostic Ultrasound System Date of Enforcement Report 3/12/2008 Class:ll PRODUCT Siemans- ACUSON Aspen Diagnostic Ultrasound System, general purpose Diagnostic Ultrasound system, Model Number: 8247887, Recall # Z-0719-2008 REASON Software error: Error affects all Aspen customer systems using the PAL video standard configuration and has a Perspective PC installed. This can lead...
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The link provided contains an academic presentation on good records management in general both paper and electronic. It identifies a number of standards that may be of value in establishing a good records management system. Records Management Standards Presentation 101706
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Company: Sunquest Information Systems, Inc., Date of Enforcement Report 2/11/2008 Class:ll PRODUCT Sunquest Laboratory Blood Bank and Blood Donor Modules v6.0.1 and v6.0.2 Distributed with Sunquest Laboratory v6.1, v6.2 and v6.3 REASON In both the Blood Bank and Blood Donor modules, a problem has been identified in Blood Order Processing. The system does not trigger...
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Recipient: Siemens Medical Solutions USA, Inc.. Product: molecular imaging diagnostic equipment device(s Date: 1/28/2008 This inspection revealed these devices are adulterated within the meaning of Section 501(h) of the Act [21 USC 351(h)], in the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity...
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SoftwareCPR Training Courses:

IEC 62304 and other emerging standards for Medical Device and HealthIT Software

Our flagship course for preparing regulatory, quality, engineering, operations, and others for the activities and documentation expected for IEC 62304 conformance and for FDA expectations. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future.  Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply.  Special deep discount pricing available to FDA attendees and other regulators.

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

Instructor: Brian Pate

Next public offering:  June 24-26, 2025 (Boston, MA)

Multiple participants from the same company: If you register 5 or more from the same company before March 15, 2025, receive a special discounted registration of $1999 per person.  These registrations may be transferred to another person at any time. Email training@softwarecpr.com to register and secure the TEAM discount.

 

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Being Agile & Yet Compliant (Public)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for registration!

  • Agile principles that align well with medical
  • Backlog management
  • Agile risk management
  • Incremental and iterative software development lifecycle management
  •  Frequent release management
  • And more!

3 days virtual (Zoom) with group exercises, quizzes, examples, Q&A.

Lead Instructor: Mike Russell

Next public offerings:

  • Americas: 11-13 February 2025
  • EU/Eastern Europe/Middle East/Africa/Atlantic/eastern South America: 18-20 February 2025
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See our post titled: 1st Quarter 2025 Agile Compliant Courses Scheduled

 

Medical Device Cybersecurity (Public or Private)

This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

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

Instructor: Dr Peter Rech, 2nd instructor (optional)

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