21

Jun

2000

FDA Guidance: Non-invasive Pulse Oximeter

devicecenter, fda

0

FDA CDRH’s guidance “Non-invasive Pulse Oximeter” for 510(k) review drafted Sept 7, 1992 and posted on the FDA website June 2000. This guidance mentions software specifically in several places (the link provided is for the full guidance) the most significant being:

“I. Is the device Software-driven? Yes/No

The firm should provide a hazard analysis, software requirements and design information, adequate test plans/protocols with appropriate data and test reports, documentation of the software development process including quality assurance activities, configuration management plan, and verification activities and summaries, commensurate with the level of concern, as discussed in the “Reviewer Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review”. The software of a pulse oximeter is a major level of concern. The hazard analysis and the most recent software version should be included in the file.”

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?”

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: TBD

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

Registration Link:

TBD

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

Registration Link:

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