FDA 510(k) Guidance – Laser Assisted Reproduction

“Guidance for Industry and FDA Staff 510(k) Class II Special Controls Guidance Document: Assisted Reproduction Laser Systems”. was issued Dec 28, 2004. This document mentions software in several places. The document at the link provided is highlighted in yellow to indicate each reference to software. The guidance.
This document states explicitly that it considers software used in such devices is moderate level of concern. It states that software lifecycle documentation appropriate for this level of concern, as indicated in its premarket submission and OTSS software guidances, should be provided to FDA in the 510(k).

This guidance lists 4 risks/hazards that are the minimum to address for this device including “ineffective treatment”.

This guidance also recommends conformance with IEC 60601-1-2 and/or IEC 61326 for EMC and one or more of IEC 60601-1, IEC 61010-1, UL 60601-1, and ANSI/AAMI ES-1 for electrical equipment safety.

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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

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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: March 7 & 28, 2024

Virtual via Zoom

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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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