April 4, 2023 So Many Adverse Event Reporting Terms in Various Jurisdictions I’ve seen companies try to combine multiple jurisdictions’ adverse event reporting requirements into a single universal set of criteria and terminology. But that approach inevitably leads to under-reporting or over-reporting in certain jurisdictions. Accordingly, my generally preferred approach is to keep the […]
<h1 class="entry-title">Author: <span class="vcard">Kevin Randall</span></h1>
FDA PMA Stakeholder Logistics Strategy
April 4, 2023 FDA PMA Stakeholder Logistics Strategy There is much to be addressed with this topic. To help us get pointed in the right direction, here are some key principles: In order to, as some informally say, be “registered in the U.S.”, Class III medical devices requiring Premarket Approval (PMA) require PMA […]
Can the EU MDR PMS Procedure and PMS Plan be the Same Thing? Part 2
April 4, 2023 Can the EU MDR PMS Procedure and PMS Plan be the Same Thing? Part 2 Carrying on from the first part of this topic from a couple days ago: Indeed, it is wise to stick with longstanding principles and corresponding normative requirements for medical device QMS documentation. And it’s essential to […]
EU MDR Article 22 Statement vs. Article 19 Declaration
April 3, 2023 EU MDR Article 22 Statement vs. Article 19 Declaration Because an EU MDR Article 22 system or procedure pack Statement of Compatibility (SoC) has a different legislative purpose than the Article 19 Declarations of Conformity (DoC) for the components inside the system or procedure pack, then the SoC and DoC need […]
Can the EU MDR PMS Procedure and PMS Plan be the Same Thing? Part 1
April 3, 2023 Can the EU MDR PMS Procedure and PMS Plan be the Same Thing? Part 1 The MDR/IVDR PMS procedures and blank templates for the PMS Plan should be Tier 2 generic quality management system (QMS) documents (i.e., procedures), while the actual PMS Plan should instead be a device-specific Tier 4 QMS […]
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 […]
ChatGPT for Regulatory Documentation
March 30, 2023 ChatGPT for Regulatory Documentation ChatGPT can only be as good as the source information which is publicly available in the electronic information ecosystem. There’s a lot of polluted information in that ecosystem, and it hasn’t necessarily been properly vetted for integrity. I did an informal mock audit of some ChatGPT-generated regulatory […]
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 […]
EU MDR Transitional Extension Regulation (EU) 2023/607 and Expired MDD/AIMDD Certificates
March 27, 2023 EU MDR Transitional Extension Regulation (EU) 2023/607 and Previously-Expired MDD/AIMDD Certificates Even if an MDD/AIMDD certificate from 25 May 2017 expired before Regulation (EU) 2023/607’s March 15 (20?), 2023 entry into force, and as long as it wasn’t “withdrawn” for cause (e.g., see EU MDR Annex IX.3.7), then placing on the […]
EU MDR: Who Must Hold the Annex XI Part A Certificate?
March 24, 2023 EU MDR: Who Must Hold the Annex XI Part A Certificate? In addition to a production-focused quality management system certificate(s) (e.g., EU Quality Assurance Certificate or EU Product Verification Certificate), the EU MDR Annex XI Part A conformity assessment route requires the “manufacturer“, depending on device class, to also hold an: […]