FDA Device Quality System Reg Signature Reqts

The Device Quality System Regulation (GMP) explicitly requires signatures in the following places:
The sections of the regulation which specifically require signatures are:

· Sec. 820.30 Design controls.c & d

· Sec. 820.40 Document controls a & b

· Sec. 820.75 Process validation a

· Sec. 820.80 Receiving, in-process, and finished device acceptance d&e.

· Sec. 820.90 Nonconforming product b

· Sec. 820.120 Device labeling b

The link provided gives the relevant text of these sections with the signature requirement highlighted.

Policy guides and enforcements practices indicate that by interpertation FDA expects signatures on specific records and procedures including any places where company procedures require additional signatures/approvals.

If electronic signatures are used for any of these then since they are signatures required by the predicate rule it is clear Part 11 would also apply for Device Manufacturers.

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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

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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!

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2-days onsite (4 days virtual) with group exercises, quizzes, examples, Q&A.

Instructors: Mike Russell, Ron Baerg

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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)

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