Tag

510k
13
Aug

When to Submit 510(k) for a Software Change

August 13, 2022
The FDA issued a final guidance entitled “Deciding When to Submit a 510(k) for a Software Change to an Existing Device)” dated October 25, 2017. This guidance clarifies for the industry how to determine which software changes to a 510(k)-cleared device require a new 510(k). It seems to reflect what the FDA has applied in...
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31
Jul

New 510(k) Exemptions for Class II Devices

July 31, 2020
List of Recently Added 510(k) Exemptions The table above comes from the Federal Register, and it explains the classification scheme (including new product codes) for the new 510(k) exemptions for Class II devices. Clearly, these five exemptions do not have far-reaching implications. This update from the FDA will likely only be significant to our clients...
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28
Jul

510(k) Approval for AI Imaging Analytics Device

July 28, 2020
On July 16, 2020, FDA issued 510(k) Approval for AI Imaging Analytics Device HealthMammo, a device manufactured by Zebra Medical Vision Ltd. As reported in the New York Times, HealthMammo is an artificial intelligence (AI) product that analyzes mammograms for suspicious lesions. Radiologists can use the HealthMammo results to prioritize which mammogram images need attention...
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25
Oct

FDA Final Guidance: Deciding if a new 510(k) is needed

October 25, 2017
The FDA issued a new Final guidance, “Deciding When to Submit a 510(k) for a Change to an Existing Device,” on October 25, 2017. The full guidance is at the link provided. This supersedes the 1997 guidance. Note that FDA simultaneously released a Final guidance for when to submit a new 510(k) for software changes...
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SoftwareCPR Training Courses:

Risk Management (Public or Private)

Our newly updated ISO 14971:2019 Medical Device Risk Management, A Software Organization’s Perspective training course is now open for scheduling!

  • Coverage of ISO 14971:2019, IEC 62304; amd1, and IEC/TR 80002-1.
  • System level hazards analysis – mapping to software, cybersecurity, and usability
  • Why FMEA is incomplete for medical device risk management.
  • How to perform software hazards analysis.
  • And more!

3-days onsite with group exercises, quizzes, examples, Q&A.

Instructors: Dr. Peter Rech, Brian Pate

Next public offering:  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 with group exercises, quizzes, examples, Q&A.

Instructors: Mike Russell, Ron Baerg

Next public offering:  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

 

IEC 62304 and other emerging standards for Medical Device and HealthIT Software (Public or Private)

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, 2nd instructor (optional)

Next public offering:  TBD

 

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