Tag

automatedtest
I cannot agree more … “The more you can divide up the behavior of your app into components, the more effectively you can test that the behavior of your code meets the reference standards in all particulars as your project grows and changes. For a large project with many components, you’ll need to run a large number of tests to test...
Read More
Since being introduced, test automation continues to evolve as new technologies are created and released.  One such evolution is Ranorex Online which has been officially released for public beta testing.  Those familiar with test automation are aware that browser plugins are a necessary evil for any web-based testing framework.  Ranorex Online attempts to eliminate that...
Read More
SoftwareCPR® is pleased to announce their Silver Service partnership with Ranorex®, an excellent test automation tool and company.  You can read other posts on our site regarding Ranorex® here. As a silver partner, SoftwareCPR® is recognized as having the quality and experience needed for developing automated tests using Ranorex®, both in regulated and non-regulated environments....
Read More
Our test team at SoftwareCPR® often uses Ranorex Automated Test Tool for automated integration level and software system level testing.   We have had very good experience with this tools for user interface testing for certain types of medical device software.  The test reports are particularly impressive and well suited for Design History Files (DHF). Accelerate testing...
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:  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:

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.