Tag

devicecenter
/docs/FDAinfusionpumplifecycleguidance-ucm209337.pdf
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/docs/FDAFiscalYear2015userFeeRates.pdf
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/docs/FDACybersecuritySafetyCommunication061413.pdf
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/docs/FDA-StandaloneClinicalDecisionSupportSystemPresentation091211.pdf
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FDA issued an analysis of Premarket Review Times under the 510(k) Program. In two samples of submissions it analyzed software deficiencies in the submissions were noted in 14-20% of the submissions analyzed. The deficiencies included no software documenation provided, missing software description, missing trace matrix, missing list of anomalies, and/or missing validation. In addition form...
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/docs/QSR21CFR820BasicIntroductionKTrautman0511.pdf
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/docs/MammographyGuidanceAddendum111610-UCM185904.pdf
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/docs/FDAInfusionPumpDraftGuidance-042310-UCM209337.pdf
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http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm187084.htm#7
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http://www.fda.gov/cdrh/devadvice/314.html
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Brian Fitzgerald Deputy Division Director, Division of Electrical and Software Engineering, FDA CDRH, Office of Science & Engineering Laboratories, provided a list of software analysis tools FDA’s laboratory uses in evaluating medical device code. This was in response to a question posed at a recent AAMI Webinar that John Murray of FDA and Alan Kusinitz...
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/Docs/ComputerizedLaborMonitoringSystemClassificationRule042407.pdf
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/Docs/ComputerizedLaborMonitoringSystemGuidance042407.pdf
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/docs/FDAComplementaryandAlternativeMedicineProductsDraft2006.pdf
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/docs/IVDDFDARegulationofSoftwarePresentation1106.pdf
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/docs/CancelCellDetectionDeviceGuidance0904-Doc1531.pdf
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FDA has been investigating putting together information on hazards of various types of devices as an aide to both FDA and industry. Sandy Weininger at CDRH has established a forum for dissemination of information on this project. If you are interested in participating or receiving updates on this effort send email to office@softwarecpr.com or directly...
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/docs/UCIFDAJohnMurray-CDRHSoftwareMEssage101902.PPT
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Below is the classifcation rule. Note that this has been used for automated sample preparation systems of some types as well.TITLE 21–FOOD AND DRUGS CHAPTER I–FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES PART 862_CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES–Table of Contents Subpart C_Clinical Laboratory Instruments Sec. 862.2050 General purpose laboratory equipment labeled...
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http://www.accessdata.fda.gov/cdrh_docs/pdf/k010605.pdf
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/Docs/FDA-DeviceLabelingandManualsGuidance.pdf
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As of 11/15/00 FDA CDRH formally recognizes “ANSI/UL 1998 Software in Programmable Components” for software submissions. Details of the recognition have not yet been posted by FDA as of 11/19/00 but the original intent was for this to be the first software standard to be recognized for devices with software of a MAJOR level of...
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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 5-7, 2024
Boston, MA

Email training@softwarecpr.com to request a special pre-registration discount.  Limited number of pre-registration coupons.

Registration Link:

Register Now

 


 

Being Agile & Yet Compliant (Public or Private)

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

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

2-days onsite (4 days virtual) with group exercises, quizzes, examples, Q&A.

Instructors: Mike Russell, Ron Baerg

Next public offering: February 12-15, 2024

Virtual via Zoom

Registration Link:

Register Now

 


 

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)

Next public offering:  TBD

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