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The Lattice (Official 3DHEALS Podcast)Author: 3DHEALS
Welcome to the Lattice podcast, the official podcast for 3DHEALS. This is where you will find fun but in-depth conversations (by founder Jenny Chen) with technological game-changers, creative minds, entrepreneurs, rule-breakers, and more. The conversations focus on using 3D technologies, like 3D printing and bioprinting, AR/VR, and in silico simulation, to reinvent healthcare and life sciences. This podcast will include AMA (Ask Me Anything) sessions, interviews, select past virtual event recordings, and other direct engagements with our Tribe.While there is no rule for our podcast content, the only rule we follow is to provide our listeners with a maximized return on their attention and time investment.Follow us on Facebook, Twitter, and Instagram @3dheals, and check out the links in the show notes. 3DHEALS Links: https://linktr.ee/3dheals DisclaimerThe content of this podcast is for informational and educational purposes only and does not constitute medical, legal, or financial advice. The views and opinions expressed by the host and guests are their own and do not necessarily reflect those of their employers, affiliates, or any associated organizations.While we discuss emerging technologies in healthcare and 3D printing, listeners should consult qualified professionals before making decisions based on the information shared. The mention of specific companies, products, or technologies does not imply endorsement.This podcast may reference early-stage innovations and concepts that are not yet FDA-approved or commercially available. Always follow regulatory guidelines and ethical standards when applying new technologies in clinical or professional settings. Language: en-us Genres: Life Sciences, Science, Technology Contact email: Get it Feed URL: Get it iTunes ID: Get it |
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Episode#127 | Lean Compliance For Medical 3D Printing With Erik Boelen
Thursday, 17 September, 2026
We talk with Erik Boelen, founder of Qase3D, about how medical 3D printing went from a regulatory free-for-all to a world where hospital print labs function as medical device manufacturers. We break down MDR, CE marking, ISO 13485, and how to stay compliant with a lean system engineers will actually use. • The early “no rules” era and why proof of quality becomes unavoidable • How MDR and CE marking work for standard medical devices • Why custom-made devices can be CE-exempt yet still heavily regulated • ISO 13485 as a process-focused QMS and where it helps most • Building a lean, day-to-day QMS instead of a paperwork vault • The MDR Portal approach and the value of lawyer-backed interpretation • Practical triggers for when a growing lab should consider ISO 13485 certification 00:00:00 - Welcome To The Regulatory Reality00:03:10 - MDR, CE Mark, And ISO 1348500:06:30 - Making Implants Before Clear Rules00:08:33 - What Custom Made Really Means00:10:20 - From Engineer To Quality Builder00:12:12 - A Lean QMS People Actually Use00:17:33 - The MDR Portal And Lawyer Support00:26:45 - Scaling Compliance Without Bureaucracy00:30:40 - The Future Of Hospital 3D Labs00:41:05 - How To Contact Erik00:43:15 - DisclaimerShow notes: https://3dheals.com/episode-127-lean-compliance-for-medical-3d-printing-with-erik-boelen/YouTube: https://youtu.be/wR7TVN4WGno?si=pvQ-Fl7VJNgNRq7FSend us Fan MailSupport the showSubscribe to our premium version and support the show. Follow us: Twitter Instagram Linkedin 3DHEALS WebsiteFacebookFacebook GroupYoutube channelAbout Pitch3D
