20

Aug

2020

My Software Is a Medical Device (SaMD). Now What?

0

My Software Is a Medical Device … if that’s you, check out this upcoming webinar. Our very own John Murray will participate in a webinar on August 25, 2020, and join a roundtable discussion with Bakul Patel, Director, Division of Digital Health at FDA. Shawnnah Monterrey, CEO @BeanStock Ventures will moderate the discussion.

You can register for the webinar at this link: https://us02web.zoom.us/webinar/register/8815964798219/WN_w4Ri7AysQUmyfIOZx2-21Q.

[View the recording of the webinar here: YouTube: “Webinar: My Software is a Medical Device (SaMD). Now What?”]

Software as a Medical Device (SaMD) products have grown exponentially over the last several years and assuring software quality can be challenging for many that are new or inexperienced in safety critical industries. Fundamental methodologies such as safety risk management, multiple levels of software verification, and structured and repeatable software development processes may be unfamiliar to SaMD manufacturers. However, many SaMD companies are bringing new and highly efficient methodologies and “software factory” tools to the table. The question is how to bring these two sides together. John and others at SoftwareCPR can help. We can bridge the gap and help SaMD companies be both agile/lean and compliant – but most importantly, assure safe medical device software.

See more of our posts related to SaMD: https://www.softwarecpr.com/tag/samd/

Let us know if we can help!

About the author

Brian Pate

Brian is a biomedical software engineer - whatever that is! Started writing machine code for the Intel 8080 in 1983. Still enjoys designing and developing code. But probably enjoys his garden more now and watching plants grow ... and grandkids grow!

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