The key guidance document from FDA regarding the software documentation required in a premarket submissions for FDA including 510(k)s, PMAs, and IDEs is the “Guidance for Industry and FDA Staff Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on: May 11, 2005  Read More

Company: Beckman Coulter IncDate of Enforcement Report 12/24/2008 Class:ll PRODUCT Vidiera NsP Nucleic Sample Preparation, Part Number: A22421, Version 1.0.41, Recall # Z-0454-2009 REASON Incorrect results: under certain circumstances, when transfer volume is not within the set range, the Vidiera NsP software does not report sample exclusion and does not flag the excluded sample in...Read More

http://www.fda.gov/cdrh/manual/pmamanul.pdfRead More

http://www.fda.gov/cdrh/devadvice/314.htmlRead More

This topic provides educational checklists related to several standards and regulations. SoftwareCPR checklists are available to paid subscribers of www.softwarecpr.com by using their login. These are only intended for use by those experienced in the related regulations and standards and are not intended to be used blindly as there may be significant interpretational ambiguities and...Read More

This topic contains several of the slide sets for presentations posted on the website. These include ONLY SOME of the FDA staff presentations as well as SoftwareCPR presentations. Others are available in the library section of the website.Read More

The pdf at the link provided is a reprint of 2 articles entitled “Sensible Software Testing” parts 1 and 2, with the permission of the author Sean Beatty of High Impact Services. Mr. Beatty was a member of the working group that developed AAMI TIR32: Medical Device Software Risk Management. He is very experienced in...Read More

This topic contains selected references for electronic records and signatures compliance. It is NOT an exhaustive set and MORE can be found by searching the document library on this website. Paid subscribers have access to all items listed while others have limited access. Other training aides may be provided to paid subscribers on request if...Read More

This topic contains selected partial document and procedure training templates as well as assorted validation tips. It is NOT an exhaustive set and MORE can be found by searching the document library on this website. Paid subscribers have access to all items listed while others have limited access. Other training aides may be provided to...Read More

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/ucm124082.htmRead More

This topic contains selected partial document and procedure training templates as well assorted validation tips for validation of manufacturing and quality system software. It is NOT an exhaustive set and MORE can be found by searching the document library on this website. Paid subscribers have access to all items listed while others have limited access....Read More

Company: GE Healthcare Integrated IT SolutionsDate of Enforcement Report 12/17/2008 Class:ll PRODUCT GE Centricity PACS RA1000 Workstation (for diagnostic image analysis). The Centricity” PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals. It is also intended for use as a clinical review workstation throughout...Read More

The pdf at the link provided is a reprint of an article entitled “Sensible Software Testing” with the permission of the author Sean Beatty of High Impact Services. Mr. Beatty was a member of the working group that developed AAMI TIR32: Medical Device Software Risk Management. He is very experienced in embedded programming and this...Read More

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...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 12/10/2008 Class:lll PRODUCT syngo MultiModality WorkPlace (MM WP). Software product (Model Number 10140720). The product is intended for use in picture archiving and communications system; Recall # Z-0324-2009 REASON Values derived from Dynamic CT data sets may be incorrect. The corresponding images are not affected. RECALLING...Read More

Company: Sunquest Laboratory SystemDate of Enforcement Report 12/10/2008 Class:ll PRODUCT Sunquest Laboratory Blood Bank and Blood Donor version 6.0.1 Distributed with Sunquest Laboratory 6.1 and 6.2 and Sunquest Laboratory Blood Bank and Blood Donor version 6.0.2 Distributed with Sunquest Laboratory 6.3, Recall # B-0149-09 REASON Software, with a glitch or defect, was distributed. RECALLING FIRM/MANUFACTURER...Read More

Company: Viasys Healthcare, Inc/Cardinal Health Inc.Date of Enforcement Report 12/10/2008 Class:lll PRODUCT Sunquest Laboratory Blood Bank and Blood Donor version 6.0.1 Distributed with GSI Audera (version 2.6 software) Viasys Healthcare, Inc. Part or (Catalog) Numbers: 2001-9700, 2001-9705, 2001-9715, 2001-9720 and 2001-9725. The GSI Audera is used as part of an audiometric test battery. It can...Read More

Company: GE Healthcare Integrated IT SolutionsDate of Enforcement Report 12/10/2008 Class:lll PRODUCT GE Healthcare Centricity Perinatal (formerly Quantitative Sentinel) System – Alert and Reminder software; automatic patient data management providing clinical information at the bedside in Labor & Delivery, Mother-Baby and the Neonatal Intensive Care Unit; GE Healthcare Integrated IT Solutions, Barrington, IL 60010 Intended...Read More

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.Read More

This is a list of ONLY SOME of the most popular software related articles and white papers on our website; additional ones can be found be searching our library. All reprints not copyrighted by SoftwareCPR are provided with permissions of the authors or publishers unless they are government issued public information. Please respect the copyrights....Read More

Company: Advanced Sterilization ProductsDate of Enforcement Report 11/26/2008 Class:ll PRODUCT STERRAD 100S Sterilizer (Product Code 10101). The sterilizer includes software and hardware components. The STERRAD Sterilization System is a low-temperature, general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices, Recall # Z-0340-2009 REASON 1) Inability of the sterilizer to detect when...Read More

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.Read More

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.Read More

Company: Sunquest Laboratory SystemDate of Enforcement Report 11/9/2008 Class:ll PRODUCT Sunquest Laboratory System. Software Version: Sunquest Laboratory v5.4.2, v6.1, v6.2 and v6.3. The system is marketed as an automated solution for managing laboratory processes including: 1) Patient registration, 2) Order entry and order modification, 3) Specimen collection, verification, suitability, and distribution, 4) Quality assurance checking,...Read More

/docs/FDA-DraftProcessValidationGiuidance111808.pdfRead More

/docs/FDA-DraftProcessValidationGiuidance111808.pdfRead More

Company: GE Healthcare Integrated IT SolutionsDate of Enforcement Report 11/5/2008 Class:ll PRODUCT Centricity Perinatal (formerly Quantitative Sentinel) System – Fluid Total Precision software; automatic patient data management providing clinical information at the bedside in Labor & Delivery, Mother-Baby and the Neonatal Intensive Care Unit, Recall # Z-0112-2009 REASON On the I&O chart, the IN, OUT...Read More

Company: Hill-Rom Manufacturing, Inc Date of Enforcement Report 11/5/2008 Class:ll PRODUCT Envision E700 Low Airloss Therapy Surface. The Envision E700 Low Airloss Therapy Surface helps prevent and treat stage III and stage IV pressure ulcers in patients who weigh between 70 lb and 400 lb and are between 4’11” and 6′ 4″ in height, Recall...Read More

Company: Draeger Medical, IncDate of Enforcement Report 11/5/2008 Class:ll PRODUCT Oxylog 3000 Emergency and Transport Ventilator Continuous Respirator with software version 1.10 pre-installed; Catalog number 2M86300, Recall # Z-0202-2009 REASON May experience an interruption of ventilation for approximately 5 seconds. RECALLING FIRM/MANUFACTURER Recalling Firm: Draeger Medical, Inc., Telford, Pa, by letter dated September 2008. Manufacturer:...Read More

Company: Varian Medical Systems Date of Enforcement Report 11/5/2008 Class:ll PRODUCT Varian RV Software Varian Treatment for Non-Varian Linacs Version 6.6.5042 and 6.6.5043; Model Number: H46; Designed to assist the operator of a radiation therapy device in providing accurate treatment setups for each patient by monitoring set up parameters and preventing the radiation therapy from...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 11/5/2008 Class:ll PRODUCT Acuson X300 ultrasound systems, ultrasound system with onscreen display. Model numbers 10037409, 10038837, 10348531. Potentially affected, but no volume currently: 10132987, 10133170, 10348532, 10348533, Recall # Z-0111-2009 REASON Thermal Index cranial (TIC) is not displayed for the Neo-Head exam type with the...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 11/5/2008 Class:ll PRODUCT Siemens Ultrasound, Acuson/Sonovista X300 ultrasound systems, software revisions 2.0.1 to 2.0.05, 3.0.01 and 3.0.02 ultrasound system with onscreen display, Recall # Z-0086-2009 REASON Incorrect value calculations by the device may result in inaccurate aortic stenosis estimates. RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA,...Read More

Company: Philips Medical SystemsDate of Enforcement Report 11/5/2008 Class:ll PRODUCT M3811B Philips Telemonitoring Clinical Review Software part of Philips Telemonitoring System, M3810A, software revision identified as Build 1.1.2.11d, B.02.07. Prescriptive medical device used to automatically collect and transmit medical information (weight, blood pressure, non-diagnostic ECG) over phone lines between provider and patient, Recall # Z-0100-2009...Read More

Company: Philips Healthcare Informatics, Inc., Date of Enforcement Report 11/5/2008 Class:ll PRODUCT iSite PACS (Picture Archiving and Communication System), software versions 3.6.28.x and 4.1.x. The product is an image management system (software package) used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Device...Read More

Company: Philips Healthcare Informatics, Inc Date of Enforcement Report 11/5/2008 Class:ll PRODUCT Philips Healthcare Informatics iSite PACS (Picture Archiving and Communications System), version 3.5.x. The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital...Read More

Company: Roche Diagnostics Corp/Hitachi LTDDate of Enforcement Report 11/5/2008 Class:ll PRODUCT Roche/Hitachi Modular E Module immunoassay analyzer, GMMI Nos. 04998642001 and 03617505001, Recalling Firm: Z-0165-2009 REASON A software bug may result in pipetting from an incorrect reagent pack and/or assigning calibration curve parameters incorrectly. RECALLING FIRM/MANUFACTURER Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by letter...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 10/29/2008 Class:ll PRODUCT Sonoline G50/G60 Ultrasound System, Software versions 1.0.0 to 1.5.0b. The product is a general purpose, mobile software controlled diagnostic ultrasound system. Model numbers 07482800, 07482818, 07482826, 07478139, 07478147, and 07482479, Recall # Z-2468-2008 REASON As a result of bugs and calculation errors,...Read More

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.Read More

Company: Philips Medical Systems Date of Enforcement Report 10/29/2008 Class:lll PRODUCT Philips Telemonitoring System Software (M3811B) used with Philips Telemonitoring System (M3810B) Revision: B.02.07 Prescriptive medical device used to automatically collect and transmit medical information (weight, blood pressure, non-diagnostic ECG) over phone lines between provider and patient, Recall # Z-2369-2008 REASON Software: If Weight Limits...Read More

Company: Medtronic Neuromodulation Date of Enforcement Report 10/22/2008 Class:lll PRODUCT a) Medtronic iCon Patient Programmer, model 3037. The Patient programmer is a hand held, battery operated, microcontroller based device for use by patients to control and monitor external and implantable devices. The minimum amount of control involves the ability to turn therapy ON or OFF;...Read More

Company: Cardinal Health NeuroCare Division Date of Enforcement Report 10/22/2008 Class:ll PRODUCT NicoletOne 5.30.2 Software when used with CSeries amplifiers in Fixed Room LTM Configurations with patient room kits. The product is used for extended monitoring of EEG in a hospital setting. The system provides connection between the patient room EEG acquisition system and central...Read More

Recipient: Steris Isomedix Inc Product:sterilizes medical devices. Date: 9/25/2008 We have reviewed your response dated July 16, 2008, and have concluded that it is inadequate because while you have opened a Correction and Preventative Action (CAPA) to address this issue, your corrective actions did not address any product that was processed prior to the initiation...Read More

Recipient: Encore Medical, LP Product:muscle stimulators and ultrasound devices. Date: 6/25/2008 1. Failure to establish and maintain adequate procedures to identify actions(s) needed to correct and prevent recurrence of nonconforming product and other quality problems, as required by 21 CFR 820.100(a)(3). For example, your firm failed to identify the action(s) needed to correct failures and...Read More

Company: Hologic, Inc., Date of Enforcement Report 10/15/2008 Class:ll PRODUCT a) Hologic Discovery Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is indicated for the estimate of bone mineral density, comparison of measured variables obtained from a given scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment,...Read More

Company: VISX Inc., a Subsidiary of AMO, Inc. Date of Enforcement Report 10/15/2008 Class:ll PRODUCT AMO WaveScan WaveFront System Version 3.90/3.901, Part Number 0070-1478. The device is used in conjunction with the VISX STAR S4 and STAR S4 IR Excimer Laser Systems, which are indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK) eye surgery...Read More

Company: Abbott Laboratories Date of Enforcement Report 10/15/2008 Class:ll PRODUCT ARCHITECT i1000SR System Assay CD ROM WW (excluding US) Special edition Version 1.01 and Version 2.0; list 01P61-01 and 01P61-02. The device is intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity, Recall...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 10/15/2008 Class:ll PRODUCT Acuson CV70 Ultrasound systems Ultrasonic Pulsed echo/doppler imaging system with Software revisions less than 4.0.0b, material number 784539, 7848521, and 7848547. Is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential...Read More

Company: Varian Medical Systems Oncology Systems Date of Enforcement Report 10/8/2008 Class:ll PRODUCT Eclipse Treatment Planning System, Client 8.1.18 and DCF 8.1.17, model number H48, Recall # Z-1612-2008 REASON A software error causes the wedge accessory calculation to be ignored in the radiotherapy treatment plan. RECALLING FIRM/MANUFACTURER Recalling Firm: Varian Medical Systems Oncology Systems, Palo...Read More

Company: SCC Soft Computer Date of Enforcement Report 10/8/2008 Class:ll PRODUCT SoftPath ASCII Software Releases 1.2, 2.1, 2.2 and 2.3, Recall # Z-2463-2008 REASON In the creation of revised report and supplemental reports diagnosis, text was inserted from another case. RECALLING FIRM/MANUFACTURER SCC Soft Computer, Clearwater, FL, by letter beginning February 23, 2006. Firm initiated...Read More

Company: SCC Soft Computer Date of Enforcement Report 10/8/2008 Class:ll PRODUCT SoftPath GUI Release Software Versions 3.17 and 4.1. Used in pathology laboratory for receiving accessing specimen reports, billing and management reports for surgical, GYN, NON-GYN and Autopsy cases, Recall # Z-2329-2008 REASON Loss of text misrepresented individual tissue diagnosis on the final diagnosis print...Read More