<h1 class="entry-title">Author: <span class="vcard">Kevin Randall</span></h1>

EU MDR PMCF: To Waive or Not to Waive

July 29, 2021 EU MDR PMCF: To Waive or Not to Waive   When is PMCF Required?   When is PMCF Required?  Do “PMCF” if, after proper premarket clinical evaluation, there remains residual risks and/or uncertainty about long-term clinical performance that may impact the benefit/risk ratio. If PMCF is indicated, then be sure the PMCF […]

FDA MDUFMA Small Business Determination (SBD) at the Pre-Revenue Stage

July 27, 2021 FDA MDUFMA Small Business Determination (SBD) at the Pre-Revenue Stage   Before addressing FDA’s MDUFMA fees and SBD program for a firm’s premarket submission when at a pre-revenue / premarket stage, my suggestion is to first remember that if a product clearance or approval [510(k) clearance, PMA approval, etc.] hasn’t happened yet, […]

EU MDR Strategy for Configurable Software

July 22, 2021 EU MDR Strategy for Configurable Software   For my clients that manufacture software-only medical devices, I have sought and implemented what I feel is the ideal:  The software design and architecture are such that there is one executable software file, but that can be configured via licensing to turn various modules on […]

EU MDR Changes to MDD DoC under EU MDR Article 120

July 22, 2021 EU MDR Changes to MDD DoC under EU MDR Article 120   When considering the requirements for revising an MDD (or EU MDR) Declaration of Conformity (DoC) associated with device changes (whether significant or nonsignificant), it’s important to know that there must always be a valid DoC that accurately represents required details […]

ISO 13485 QMS Planning vs. Quality Plans

July 19, 2021 ISO 13485 QMS Planning vs. Quality Plans   I think it’s important to remember that the general quality management system planning and set-up called for by ISO 13485 clause 5.4.2(a) is fundamentally distinct from clause 7.1’s product/project/object/output-oriented planning.  If they were the same, then ISO TC/210 would not have separated and distinguished […]

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 […]

FDA Remote Regulatory Assessment

July 16, 2021 FDA Remote Regulatory Assessment   For the U.S. medical device jurisdiction, a client and I a couple weeks ago went through an FDA Remote Regulatory Assessment (RRA).  Here’s a recap:   FDA contacted the firm and informed them that, due to the current SARS-CoV-2 (COVID-19) situation, the FDA is conducting inspections [called […]

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 […]

ISO 14971 Estimating Probability of Occurrence of Harm

July 13, 2021 ISO 14971 Estimating Probability of Occurrence of Harm   Based on the aforesaid flexibility (see my earlier blog post) allowed by ISO 14971 (e.g., see the third paragraph of ISO/TR 24971 section 5.5.2) for how to estimate probability of occurrence of harm, one might employ a variety of probability expressions.  For example, […]

EU MDR Scope and Applicability of GSPR 10.4.1

July 12, 2021 EU MDR Scope and Applicability of GSPR 10.4.1   I think there is a good possibility that GSPR clause 10.4.1’s reference both to “invasive” and to “come into direct contact with the human body” may just be an ambiguous redundancy in describing invasive devices, as I have a hard time imagining an […]