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Today, FDA issued a new Part 11 guidance draft that reduces the scope and burden of Part 11 significantly.  It essentially suspends enforcement on legacy systems existing prior to the rule’s effective date in 1997 and eliminates: enforcement related to audit trails, electronic copies, and maintenance of electronic records by focusing on meeting the intent...
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ADVAMED and NEMA sent a letter to Dr. Feigal (Director of FDA’s Device Center) raising concerns about Part 11 based on a recent meeting with FDA. They are objecting to the return of Part 11 responsibility to the drug center with no formal device center involvement and the potential that the drug center will issue...
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Company: MAK-SYSTEM S.A. International GroupProduct: Progesa Soundex file module Date: 02/06/2003 All users are not notified of existing problems or fixes until a user encounters the problem. Software corrections are only provided to the user that discovered and reported the problem and not to other users of the computer system/software. For example There were no...
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Although the HIPAA Privacy Rule directly effects “Covered Entities” medical device and pharmaceutical manufacturers may be involved in inadvertent release of private patient information and must deal with requirements from their customers that are Covered Entities. It was reported that: Eli Lilly, already has settled with eight states and the Federal Trade Commission for $160,000...
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Company: Merits Health Products Co. Ltd. Product: Powered wheelchairs, electric scooters and oxygen concentrators Date: 02/04/2003 Failure to validate computer software for its intended use according to an established protocol when computers or automated data processing systems are used as part of production or the quality system, as required by 21 CFR 820.70(i). For example,...
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Company: Misys Healthcare Systems, Inc.Date of Enforcement Report: 1/29/03 Class: II PRODUCT Misys Blood Bank System. Recall # B-0455-3. CODE Version 5.2, 5.23, and 5.3. REASON Defect in the design of blood bank software programs could result in the release of unsuitable blood product. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Inc. (formerly Sunquest Information Systems), Tucson,...
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ADVAMED provided a white paper to FDA as part of the Part 11 Industry Coalition. This paper proposes that health and safety risk be used to properly interpret and apply Part 11 and that this approach would resolve some of industry’s issues rather than an approach focused on fraud. ADVAMED BLiebler Part11 Risk Paper
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Company: Lexicor Medical Technology Inc.Product: DataLex Web portal Date: 1/16/03 We are writing to you because on July 3 through 17, 2002, an investigator from the Food and Drug Administration (FDA) collected information that revealed a serious regulatory problem involving the product known as “DataLex” web portal which is made and marketed by your firm....
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Company: Beckman Coulter, IncDate of Enforcement Report: 1/15/2003 Class: III PRODUCT EXPO 32 Software. Recall # Z-0407-3. REASON Software contains errors that might affect Cytometry instruments. CODE Versions 1.0, 1.1B, and 1.2. RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA, by letter on May 20, 2002. Firm initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE...
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Company: Siemens Medical Solutions USA Inc.Product: Diagnostic x-ray system Date: 1/14/03 You are requested to report the results of your investigation and follow-up action to this office within thirty (30) working days of receipt of this letter. Your response should include the date that the corrective action was completed and copies of service records and/or...
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Company: Philips Medical SystemsDate of Enforcement Report: 1/8/2003 Class: II PRODUCT AXIS/IRIX Gamma Camera System, controlled with Odyssey computers, operating with version 8.5 software. Recall # Z-0353-3/Z-0364-3. The systems are controlled with Odyssey computers that are connected to a Prism gantry. Some Odyssey computers operate as stand alone workstations. A Prism XPVTSystem, Tomography, Computed, Emission,...
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Company: Baxter Healthcare CorpDate of Enforcement Report: 12/25/02 Class: II PRODUCT HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems; Made in U.S.A.; Recall # Z-0334-3/Z-0339-3. The following models are affected: a) Baxter HomeChoice Automated PD System, catalog 5C4471, 115 volt; b) Baxter HomeChoice Automated PD System, catalog 5C4474, 220 volt; c) Yume Automated PD System,...
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Company: Mediware Information Systems, IncDate of Enforcement Report: 12/18/02 Class: III PRODUCT Hemacare Blood Bank Data Management System, Recall # B-0301-3 REASON Blood bank computer software, which had a defect that could cause antigen test results to be associated with the wrong unit or sample, was distributed. CODE Version 5.2b(b). RECALLING FIRM/MANUFACTURER Mediware Information Systems,...
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Company: Eastern Medical Equipment Distributors Inc.Product: Oxygen USP and Oxygen Analyzer Date: 12/17/02 Failure to routinely calibrate mechanical and electronic equipment used in the transfilling of Oxygen USP or keep records of calibration according to a written program designed to assure proper performance as required by 21 CFR 211.68. For example, there was no documentation...
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Company: Eastern Medical Equipment Distributors Inc.Product: Oxygen USP and Oxygen Analyzer Date: 12/17/2002 Failure to routinely calibrate mechanical and electronic equipment used in the transfilling of Oxygen USP or keep records of calibration according to a written program designed to assure proper performance as required by 21 CFR 211.68. For example, there was no documentation...
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Company: Hamilton CompanyDate of Enforcement Report: 11/13/02 Class: II PRODUCT a) Hamilton Brand Sunrise Software – for the Microlab AT series Instruments; b) Hamilton Brand Sunplus Software – for the Microlab AT Plus and AT Plus 2 series Instruments; Recall # B-0115-3. REASON Automated pipette software, which had a glitch or defect, was distributed. CODE...
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On Nov 12, 2002 FDA released its 5th draft Part 11 guidance “Electronic Copies of Electronic Records”. The date in the document itself is August 2002. This draft is at the link provided. It addressed content, format, and integrity requirements for provision of records in electronic form to FDA.It: – allows that electronic copies do...
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Company: UPC Medical Supplies Inc.Product: Sacred Crane TDP Lamp, QL-Wide Band Spectrum Apparatus and other products Date: 11/01/2002 Claims for the Stimplus II Acupoint Locator & Stimulation device include that it “locate[s] acupoints and then stimulate away the pain electronically at the touch of a button without needles. Acupoints are detected with sound and light…Stimplus...
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Company:Beckman Coulter, IncDate of Enforcement Report: 11/6/02 Class: II PRODUCT Synchron LX 20, Part # 466101; Synchron LX 20 Pro, Part # 466200. Recall # Z-0150-3. REASON Low results on the cartridge chemistry assays, syringe valve seat issue. CODE All units with software version 2.1 are affected. RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA, by...
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Company: UPC Medical Supplies Inc…Product: Sacred Crane TDP Lamp, QL-Wide Band Spectrum Apparatus and other products Date: 11/1/2002 Claims for the Stimplus II Acupoint Locator & Stimulation device include that it “locate[s] acupoints and then stimulate away the pain electronically at the touch of a button without needles. Acupoints are detected with sound and light…Stimplus...
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Company: Heimann Systems CorporationProduct: Cabinet x-ray system Date: 10/30/2002 21 CFR 1020.40(c)(10) requires that x-ray systems designed for security screening of carried possessions in public facilities shall be provided with means to insure operator presence at the control area in a position which permits surveillance of the ports during generation of x-radiation. We observed that...
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Company: Beckman Coulter, Inc.Date of Enforcement Report: 10/30/02 Class: III PRODUCT Access 2 Immunoassay Systems — Systems Software Versions 1.0; 1.1; 1.2; and 1.3.1. Recall # Z-0124-3. REASON Erroneous result flags can result on printed reports and screen displays in rare circumstances. CODE Product Name: Access 2 Software Part Number: 973074 Lot Number Software Version...
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Company: Siemens Medical Systems, IncDate of Enforcement Report: 10/23/02 Class: III PRODUCT Somatom Sensation 16 systems. Software upgrade from Somaris/5 VA50A to VA50B. Recall # Z-0109-3. REASON Scans may be aborted if scans are started manually. CODE Model Number 7393114. Four serial numbers 50012, 50022, 50025, 50029. RECALLING FIRM/MANUFACTURER Recalling Firm: Siemens Medical Systems, Inc.,...
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/docs/UCIFDAJohnMurray-CDRHSoftwareMEssage101902.PPT
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Company: Unico Holdings Inc.Product: Over-the-counter drug products Date: 10/18/02 In answer to observations made about not performing specific gravity testing as required by the covering monograph, your response states your belief that under certain circumstances not every analytical procedure listed in an article’s monograph needs to be performed, but offers no documentation or historical data...
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Company: Roche Diagnostics CorpDate of Enforcement Report: 10/16/02 Class: II PRODUCT Roche brand Elecsys 2010 clinical chemistry analyzers. Recall # Z-0005-3. REASON Possibile incorrect breast cancer marker results. CODE Serial numbers 1058-11, 1164-70 and 0806-10. (All analyzers with software version 06-01.) RECALLING FIRM/MANUFACTURER Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by telephone on August 8,...
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Company: Abbott Laboratories Inc.Product: Drug products Date: 10/15/2002 Failure to assure that automated equipment will perform a function satisfactorily during the manufacturing process for your drug products [21 CFR 211.68]. For example, The _____ process control computer monitoring system that is used to monitor various production and processing operations (e.g., operation conditions, equipment and component...
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Company:Serv-A-Pure Co.Product: Water purification systems for hemodialysis Date: 10/10/2002 Design Control and Design Inputs and Outputs. Your response to FDA-483 observation # 4 addresses the specific observation that the records were not signed and dated. We are concerned that the records referred to in this observation are maintained on a computer system, and your response...
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Company: Spacelabs Medical, IncDate of Enforcement Report: 10/9/02 Class: II PRODUCT Recall # Z-1395-2/Z-1401-2. a) Telemetry Digital Processors Models 90342, 90344, 90346, 90348. Recall # Z-1395-2/Z-1398-2; b) Integrated Multiparameter Module Model 90470. Recall # Z-1399-2; c) Telemetry Receiver Module Model 90478. Recall # Z-1400-2; d) Ultarview Command Module Model 90496. Recall # Z-1401-2. REASON ECG...
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Company: Misys Healthcare Systems, IncDate of Enforcement Report: 10/9/02 Class: II PRODUCT Cytomics RXP software. Recall # Z-1387-2. REASON When analyzing multiple listmode files using a multi-file analysis protocol, incorrect percentage results may occur if “% in Regions” is selected. CODE Version 1.0. RECALLING FIRM/MANUFACTURER Beckman Coulter Inc., Brea, CA, by letters dated May 15,...
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Company: Misys Healthcare Systems, IncDate of Enforcement Report: 10/9/02 Class: II PRODUCT Misys Laboratory. Recall # Z-0002-3. REASON Software anomaly. Quality assurance flags were not appearing as they should on cumulative reports. CODE Versions 5.2, 5.23 and 5.3. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Inc., Tucson, AZ, by fax July 5, 2002. Firm initiated recall is...
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Company: Misys Healthcare Systems, IncDate of Enforcement Report: 10/9/02 Class: II PRODUCT Misys laboratory version 5.3 with custom Result Interface 11. Recall # Z-1405-2. REASON Software anomaly causing mixing of patient data. CODE Version 5.3 with custom Result Interface 11. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Inc., Tucson, AZ, by fax on June 13, 2002. Firm...
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Company: Abbott Laboratories, IncDate of Enforcement Report: 10/02/02 Class: II PRODUCT Aeroset Software Version 1.01ER000. Recall # Z-1352-2. REASON Sample results may be skewed by failure to properly ‘blank’ the sample. CODE Catalog number 2-94815-01, The AEROSET Software is not controlled by lot or control numbers. RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc., Irving, TX, by telephone...
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Company: Misys Healthcare Systems, IncDate of Enforcement Report: 10/02/02 Class: II PRODUCT Misys Laboratory. Recall # Z-1377-2. REASON Software anomaly. Footnotes are incomplete and do not print on reports. CODE Version 5.3. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Inc., Tucson, AZ, by fax on August 16, 2002. Firm initiated recall is ongoing. VOLUME OF PRODUCT IN...
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Company: Misys Healthcare Systems, IncDate of Enforcement Report: 10/02/02 Class: II PRODUCT Misys Laboratory. Recall # Z-1378-2. REASON Software anomaly. When original results were modified or deleted in function MEH, original/unmodified results were saved. CODE Versions 5.2, 5.23, 5.3. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Inc., Tucson, AZ, by fax July 5, 2002.Firm initiated recall is...
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Company: Medical Data Electronics, IncDate of Enforcement Report: 10/02/02 Class: II PRODUCT Defibrillator/ Pacer Medical Research Laboratories external adult defibrillator paddle set- used with Medical Data Electronics Escort defibrillator pacer models 20201 and 20202. Recall # Z-1360-2. REASON Intermittent operation of the paddles. CODE Serial Numbers 10392 thru 10540. RECALLING FIRM/MANUFACTURER Recalling Firm: Medical Data...
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Company: Med-Mart Pulmonary ServicesProduct: Inhalation solutions Date: 9/30/02 Failure to perform routine calibration and to assure proper performance of all automatic, mechanical, and electronic equipment used in the manufacture, processing, packing, and holding of a drug product [21 CFR 211.68]. For example, your filtration unit, _____ small batch filler unit, industrial scale, _____ Pump, and...
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Company: Becton Dickinson Microbiology SystemsDate of Enforcement Report: 9/25/02 Class: II PRODUCT Becton Dickinson’s EpiCenter Data Management System software. Recall # Z-1338-2. REASON IVD software defect may cause incorrect patient results to be reported. CODE EpiCenter Software, version 3.20B, Catalog #441007. RECALLING FIRM/MANUFACTURER Becton Dickinson Microbiology Systems, Sparks, MD, by letter on August 1, 2002....
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