Tag

aami
SoftwareCPR® partner Mike Russell is attending the AAMI/FDA neXus medical device standards conference this week in Washington D.C., and chairing a panel. This year’s conference has added a third standards success track: application. Accordingly, Mike is chairing a panel session today on “Reducing Submission Rejections and Recalls with Software Standards.” In addition to his experience...
Read More
"AAMI TIR69: Risk Management of Radio-frequency Wireless Coexistence for Medical Devices and Systems" available for purchase
Read More
AAMI TIR50: 2014 “Post-market surveillance of use error management” addresses use error detection for medical devices from the clinical, manufacturer, patient, user, and regulatory perspective. The goal is to provide guidance on how these individuals can best collect, assess, and leverage post-market use error data to mitigate product risk, and to improve product safety and...
Read More
See the attached press release from AAMI and UL regarding their collaboration to produce a series of interoperability standards. AAMI UL Interoperability Press Release
Read More
AAMI has published “AAMI TIR45: 2012 Guidance on the use of AGILE practices in the development of medical device software.” FDA staff was involved in development of this guidance for compliant use of Agile methods. The document can be ordered from AAMI.org.
Read More
The pdf at the link provided is a reprint of an article entitled “Risk-Based Validation of Multilingual Medical Devices” co-authored by Alan Kusinitz, Managing Partner of SoftwareCPR, and Kai Simonsen of the Crimson Life Sciences division Transperfect Translations for the AAMI Biomedical Instrumentation and Technology journal and published in the Summer of 2007. Reprinted with...
Read More
AAMI Standards Conference Software Session 2005 including 4 FDA presentations The following are all included in the pdf at the following link: AAMI Standards Conference Software Session 2005 Review of Software in Premarket Submissions (new guidance for CDRH and CBER) – David S. Buckles FDA CDRH ODE Cybersecurity for Networked Medical Device Containing (OTS) Off-the-Shelf Software...
Read More
This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. At AAMI’s International Standards Conference on March 11 2003 FDA’s CDRH Software Compliance and Part 11 Representative (John Murray) gave the first presentation on FDA’s changes in its approach to Part 11.  The slides from this presentation can be...
Read More
This content is only available to Premium Level or higher subscribers.  See our Subscribe page for information on subscriptions. At AAMI’s International Standards Conference on March 11 2003 FDA’s CDRH Software Compliance Expert and AAMI Software Committee co-chair (John Murray) gave a presentation on FDA’s software message and the role standards can play to benefit industry and...
Read More
At a half-day breakout session on the AAMI Medical Device Software Standard, the HIMA Conformance Assessment Tool, UL 1998, the FDA Off-the-shelf software guidance, and other software standards and policy initiatives for the medical device industry was presented as part of the annual AAMI International Standards Conference. FDA and several industry speakers participated. John Murray,...
Read More

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

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.