SoftwareCPR MobileApp – iPhone & Android

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 have information available offline when the WiFi is acting up or meeting clients in a secured environment. I’ve personally used this app multiple times and have found that it saves me time looking up FDA regulations and guidance since I already have my smartphone on me at all times. Instead of dusting off your reference books, trying to find your pocket guide, or trying to find the right FDA database, download our free app by searching in the app store for “SoftwareCPR” or click the links above and let this be your easy comprehensive reference guide.

Each app contains the following FDA medical device regulations and guidance:

  • 21 CFR 801: Labeling

    SoftwareCPR's app shows FDA Regulations and Guidance related to medical devices right on your smartphone or tablet!
    SoftwareCPR’s FDA Regulations and Guidance App!
  • 21 CFR 803: Medical Device Reporting
  • 21 CFR 806: Medical Devices; Reports of Corrections and Removals
  • 21 CFR 820: Quality System Regulation
  • 21 CFR Part 11: Electronic Records; Electronic Signatures
  • Guidance: General Principals of Software Validation
  • Guidance: Content of Premarket Submissions for Software Contained in Medical Devices
  • Guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices

To view a regulation or guidance, choose one from the list and collapse/expand the section you want to see. No ads will show up, no internet connection is needed, and we will never sell your data!

If you like the app then please don’t forget to rate us in the app store! Don’t forget to ping us with suggestions, feature requests, or bug reports! We try our best to accommodate everyone and love hearing feedback.

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:  June 5-7, 2024
Boston, MA

Email to request a special pre-registration discount.  Limited number of pre-registration coupons.

Registration Link:

Register Now



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: Tuesday, January 23 through Friday, January 26 from at 11 am – 3 pm EST

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

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