April 18, 2023 Design & Development Includes Regulatory Submissions Premarket regulatory submissions [e.g., U.S. FDA 510(k) / PMA; European Technical Documentation Submissions, Canadian Device Licensing, Australian ARTG registration, etc.] need to be driven by, and documented in association with, the design and development process and documentation. For example, both the FDA (via the QS […]
<h1 class="entry-title">Category: Design & Development</h1>
Design Plans: Clearly Identify Design Team Members/Contributors
April 11, 2023 Design Plans: Clearly Identify Design Team Members/Contributors It’s important to be mindful that ISO TC/210 and FDA expect the design team and its members’ roles to be very clearly defined (i.e., in the design plan). FDA says that, “The importance of defining responsibilities with clarity and without ambiguity should be recognized.” ISO […]
Regulatory Review of Marketing Literature and other DHF Elements
April 3, 2023 Regulatory Review of Marketing Literature and other DHF Elements Virtually all aspects of design and development are officially regulated activities, especially labeling/advertising development. Moreover, the quality management system demands that all personnel whose work can affect compliance shall be competent regarding their respective assignments. But even if sales and marketing (or other […]
ISO 13485: Design & Development Obligations of Contract Manufacturers
March 29, 2023 ISO 13485: Design & Development Obligations of Contract Manufacturers As a general rule, a contract manufacturer who doesn’t perform any design and development for the subject device is thereby not required to have design and development in the scope of that contract manufacturer’s ISO 13485 certificate. So its certificate scope statement […]
Biological Evaluation for Reusable Devices: Shelf Life vs. Expected Life
March 22, 2023 Biological Evaluation for Reusable Devices: Shelf Life vs. Expected Life Biological evaluation for reusable devices may reasonably not be focused on “shelf life”. The heart of this question hinges first on general medical device principles regarding shelf life (or lack thereof) vs. stability over the device’s lifetime. Much can be said […]
DHF Documentation of Design Changes
March 13, 2023 DHF Documentation of Design Changes Neither the FDA nor ISO 13485 mandate a required format for the Design History File (DHF). Accordingly, we have latitude to decide what structure, format, and organizational approach we use to meet the basic regulatory requirements and objectives for the DHF. Accordingly, if your system does […]
Regulatory is Part of the Design and Design Team: Part 2
March 2, 2023 Regulatory is Part of the Design and Design Team: Part 2 Here are a few more practical examples generally demonstrating that Regulatory can’t be separated from the design team. For example, if a Regulatory staffer compiled the GSPR matrix or an FDA 510(k), then that unfortunately means that staffer wrote […]
Regulatory is Part of the Design and Design Team: Part 1
March 2, 2023 Regulatory is Part of the Design and Design Team: Part 1 ISO 13485 demands that regulatory requirements be included in the required design inputs and outputs along with the corresponding verification (and maybe also validation depending on how a client approaches it). Consequently, the person who authored those regulatory design inputs, […]
Risks from an Inadequate Development Process for Software
July 19, 2021 Risks from an Inadequate Development Process for Software The most fundamental reason for medical device design and development controls (e.g., ISO 13485 clause 7.3; the U.S. FDA’s 21 CFR 820.30, etc.) is to control risks that come from an inadequate development process. That fact is unequivocally true and stands in stark contrast to […]
Showing Conformity to Standards
July 16, 2021 Showing Conformity to Standards Regardless of the source of a request for evidence showing conformity with applicable standards, a pivotal underlying fundamental remains the same and drives the answer: Conformance with standards is generally a design/development verification and/or validation activity. Therefore, the general rule of thumb is that there needs to […]