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 […]
<h1 class="entry-title">Category: Design & Development</h1>
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 […]
FDA & ISO DMR/MDF vs. “Design Output”
April 1, 2019 FDA & ISO DMR/MDF vs. “Design Output” Remember that the DMR is intrinsically linked to the design control process. The DMR is by formal definition a design output (see my preceding blog post). It unequivocally lives and breathes in direct relationship to the design control process. A properly-maintained DMR never becomes decoupled […]
FDA & ISO 13485 Design Outputs and the DMR
FDA & ISO 13485 Design Outputs and the DMR Remember that for FDA-regulated firms, design output is formally defined in 21 CFR 820.3(g) as, “…the results of a design effort at each design phase and at the end of the total design effort. The finished design output is the basis for the device master record. […]