Patient Matched Guides

Patient Matched Guides

FDA released a draft guidance document for patient matched guides for orthopedic implants.  The guidance provides recommendations to manufacturers regarding the design-and-production process for these types of devices.  Patient matched guides, as the name implies, are unique to the patient and are created to assist pre-surgical planning.  The clinician is better able to visualize proper design of the implant and plan surgical actions to enhance intended use.  Most often, the overall planning process involves acquisition of patient specific images, design of implants and surgical fixtures tailored to the patient images, and streamlined production processes to achieve manufacture of the implants and fixtures.

SoftwareCPR Partner Windi Hary and I have provided a few notes and key portions of the guidance and have provided our marked up guidance as a job aid to SoftwareCPR website subscribers.  Retrieve the marked up guidance here:  SoftwareCPR markup of patient-matched-guides-ortho-guidance

Keep in mind that this guidance does not supersede other guidance from FDA regarding software quality, but is meant to focus and draw attention to key software quality assurance aspects for Patient Matched Guides.

Other related SoftwareCPR thoughts on the Final Guidance on Content of Premarket Submissions for Device Software Functions

About the author

Brian is a biomedical software engineer - whatever that is! Started writing machine code for the Intel 8080 in 1983. Still enjoys designing and developing code. But probably enjoys his garden more now and watching plants grow ... and grandkids grow!

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

Registration Link:




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
Partners located in the US (CA, FL, MA, MN, TX) and Canada.