<h1 class="entry-title">Category: Design & Development</h1>

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 […]

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 […]