Jun

2000

Obsolete- Oxygen Conserving Device 510(k) Rvw

FDA CDRH’s “Guide for Oxygen Conserving Device 510(k) Review” was considered obsolete as of 12/21/01 and may be used for historical purposes

Drafted Feb 1989 and posted on the FDA website June 2000. This guidance mentions software specifically in two places (the link provided is for the full guidance):

” B. Specification Criteria …

7. Is the device solid-state controlled and hard-wired or does the device contain a microprocessor? Does the microprocessor controlled device conform to the moderate software concern guidance document?

…

C. Alarms …

3. If the device is software controlled, is there an alarm package for microprocessor failure? Is the design fail-safe; Is there an alarm alarm?”

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

Lead Instructor: Mike Russell

Next public offering: Dec 3, 4, & 5, 2024 – 12:00 pm to 5:00 pm CET

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.

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Next public offering: TBD

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Registration Link:

TBD

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

Obsolete- Oxygen Conserving Device 510(k) Rvw

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