Test Driven Development

Test driven development (TDD) is the creation and execution of automated tests early in development which fail, by design, until a programmed element is implemented. There are many terms to describe the process, but few will refute its value. Re-discovered in 2003, manufacturers are taking hold of this methodology, ensuring new hires can successfully and individually implement TDD on their own code.

TDD is the new norm because it provides many benefits. These benefits are not limited to: fewer defects, simpler code, better maintainability, and increased productivity. Although more time is spent developing the automated unit tests, studies suggest defects present in a released product are decreased by over fifty percent. Simpler code not only decreases defects but also leads to better maintainability which produces a better quality product. A natural result of these benefits is increased productivity and quality. When defects are minimized at the developmental level, less time and resources are needed during the testing phase, saving time and money.

Academic curriculum are changing, bridging the TDD gap and employers are hiring TDD qualified personnel when given the choice. Companies and educators are taking notice that the benefits far outweigh the hindrances relating to quality and productivity. Its easy to see that TDD is here to stay. Contact SoftwareCPR® for assistance in establishing an effective and compliant TDD process at your company today.

SoftwareCPR Training Courses:

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

Register Now


 

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

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