26

Sep

2017

Agile Methods in Medical Device Companies

0

A short, short time ago, in this very own galaxy some companies were not making blockbusters, but medical devices. Whispers of quicker development times and better testing made the way past the water cooler until it became time to indulge and implement the mythical software development lifecycle. With the changes came weird language and rumors that the company would now create epic stories and employees would be running very fast around the building (e.g., sprinting).

Spoiler alert: There is no forced exercise, but employees would actually be writing stories and epics.

Conventional waterfall models use versions and products as the development rollercoaster. Someone (hopefully) writes the software requirements, then an exclusive group reviews and approves them. Then came the very difficult task of software design and how it should be documented. And, “what about the architecture – did it ever get copied from the whiteboard into a document?” Next, the software is implemented by “I code – I don’t document” Donnie and when that is almost finished, “do I have to test all that” Connie starts testing the software.
Agile software development models differ such that requirements are written by small group stakeholders, in the form of epics and stories. So how do epics and stories fit into FDA regulations and international standards without duplicating work and thereby negating some of the efficiency of agile?

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
Agile risk management
Incremental and iterative software development lifecycle management
Frequent release management
And more!

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.

Instructor: Brian Pate

Next public offering: TBD

Call or email now to schedule a private, in-house class. The fall schedule is filling up!

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

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