Case Management in Patient-Specific Surgical Planning, Surgical Guides, and Custom-Made Implants Case management plays a vital role in the production and implementation of 3D-printed patient-specific surgical planning, surgical guides, and custom-made implants. Not only does it ensure streamlined operations, but it also helps achieve traceability—a fundamental requirement of a Quality Management System (QMS) under ISO …
Author: Dr Boolean
Risks in medical 3D printing
Risks are everywhere! As part of your QMS, analyse your risks. It’s convenient to analyse the risks per step in the workflow below. Do this with a multidisciplinary team, so you can approach this from various angles. This workflow reflects the elements of the Ishikawa diagram, or 5M method: Sometimes you even see another M: …
The best software for QMS…
…is not QMS software (and is affordable!) In this whitepaper I share the lessons learned while looking to implement an ISO13485 Quality Management System for a medical device company that 3D prints custom-made medical devices and that have proven to be applicable to other medical devices.
Practical guide to ISO 13485
Where to start with your QMS for ISO 13485? Struggling to start with your QMS? In this practical guide I share my proven approach in setting up and implementing an (ISO13485-based) Quality Management System for a (3D printing) medical device company or Point-of-Care 3D Lab.
Build a digital QMS for ISO13485…
…without QMS software Most people who want to start building a Quality Management System (QMS) look at dedicated QMS software first. So did I years ago. But after a thorough “Quest for Quality” I chose a more efficient ánd economical approach. I wrote a whitepaper to share the lessons learned while looking to implement an …
QMS structure
Procedures for ISO 13485 The image below shows a visual overview of the procedures (tier 1 and 2) and their interactions in a QMS based on ISO 13485. (Requirement 4.2.2c Quality Manual: “a description of the interaction between the processes of the quality management system“). NOTE: The structure shows how my QMS for ISO 13485 …
Guidance PMD
Personalized Medical Devices – Regulatory Pathways Last week, the IMDRF released the second edition (2023) of document IMDRF/PMD WG/N58. The previous edition dated from 2020. In this latest version, they elaborate a bit more on the concept of the Medical Device Production System (MDPS).
Research Report
Quality challenges in medical 3D printing The report summarizes the findings of my research into the challenges in quality management for medical companies/facilities that use 3D printing and would like to get ISO13485 certified. I would like to thank all the people who participated in this study and who completed my questionnaire!