FDA CDRH 21 CFR 820 Quality System Regulation

FDA CDRH’s “Quality System Regulation ” issued October 7, 1996 under the GMP regulation 21 CFR Part 820. This regulation specifically requires software validation as a part of design validation (820.30g) for medical device software. Note that this is required even for Class 1 devices (820.30a) if they contain software which means that the device might be exempt from a 510(k) Submission requirement but that does not exempt the manufacturer from validating the software and implementing design controls for that device. Section 820.70i Automated Processes requires software validation when computers or automated data-processing systems are used as part of production or the quality system. Section 820.181 Device master record states that software specifications are to be part of the DMR. The preamble of the regulation responds to a number of comments on the earlier draft of the regulation in relation to design control and software. It is important to note (especially for companies where software is the product) that all sections of this regulation need to be considered even if they don’t explicity mention software (for example, preventive and corrective action, auditing, document control, purchasing controls, management review, etc.).

While this regulation established requirements for design control and for software validation explicity in a regulation FDA submission and enforcement practices had essentially required software validation for medical devices since the late 1980s as evidenced by the 1991 software submission guidance and the frequent software validation citations in warning letters.

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.

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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

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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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