By

Paul Felten
It’s nice to have medical device FDA regulations and guidance accessible without navigating through old websites or lugging printed copies around. Thankfully, SoftwareCPR’s free iOs and Android apps allow you to quickly view medical device regulations and guidance on your smartphone offline! As medical device consultants, we know from experience how important it is to...
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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...
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Testing activities should neither end with the release of the product nor once test documentation is complete, but should continue with the reduction of any test debt. Test debt is essentially a form of technical debt. Like technical debt, test debt is incurred during a project when compromises are made in the creation of test...
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A security company indicated the following: … many companies received emails from Amazon indicating that their AWS S3 bucket policies were left configured as “publicly accessible”. These publicly accessible policies allow potentially sensitive cloud data exposed to cybersecurity threats, and likely are not the intention of the Amazon customers. Amazon recommended that each “bucket” policy...
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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...
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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....
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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...
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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

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

 


 

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: 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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