Erik Boelen and his firm, QasE3D, are quality management consultants to the 3D printing industry.He partnered with Waveland European Lawyers to create a simple tool to help companies stay compliant.Meant for adherence to Medical Device Regulation (MDR) in the European Union, the tool makes it easier for orthopedic labs, hospitals, custom device manufacturers, and medical labs to comply.
It’s a text-based platform that takes you step-by-step through MDR adherence.Printing custom medical devices is difficult enough.Safety, production economics, and funding are difficult while safety and liability are always concerns.
In Europe, MDR adherence is a requirement for anyone wanting to make custom medical devices.Your hospital lab, orthopedic device, and Point of Care 3D printing effort must all be compliant.The adherence process is tedious, and one of the requirements is to have a Quality Management System (QMS).
A QMS, in essence, is a set of methods and procedures that lead to your understanding of who and what is going on in your company and what can affect outcomes and quality.Under MDR, ISO13485 defines a compliant QMS.If you follow the process set out in ISO13485, you are mostly, but not completely, compliant.
Additional MDR steps have to be undertaken.MDR Management System.Image courtesy of QasE3D.
Erik realized that the ensuing uncertainty, coupled with the time sink of implementing a QMS in the first place, is daunting.He partnered with Waveland to make an MDR-compliant tool.The platform aims to encompass all steps needed for compliance.
Meant for hospital 3D print labs and other custom device manufacturers, the tool should be easy to use and set up.If you make anatomical models, patient-specific implants, or surgical guides, this could make your life a lot easier.The platform has been updated to ensure compliance and is available for an annual fee.
Erik trains you on the app and gives annual update training on rule changes and best practices.A yearly audit is also conducted.The platform includes all relevant MDR policies.
The tool has 18 distinct chapters.Navigating them is easy, and all applicable checkboxes, decision trees, and fields are available.The app tracks players in your organization and product elements.
Erik says, “When you hit 100% in the platform, you know you are compliant with the MDR for custom-made devices.” You can use it as a standalone tool or within an existing QMS for easier compliance.Erik also noted that, “While working with several Point-of-Care labs to build their ISO13485-based QMS, I got more questions about the MDR than about ISO13485.Because building a QMS is not the goal, MDR compliance is the goal.
To fully grasp the MDR, I realized we need European Lawyers, which led me to Waveland.Their MDR portal was an eye-opener; I never expected MDR compliance could be obtained so easily and practically!” Benedikt Marijnen of Waveland European Lawyers explained, “It’s in my DNA to want to make everything simple.With Waveland, we translated the complex MDR into easily understandable policies and actions.
This MDR Management System is recommended by the National Podiatry Association in the Netherlands and together with Qase3D, we adapted the system to support European hospitals who produce custom-made devices at Point-of-Care.“The MDR legislation requires compliance to this law.That means internal policies and procedures (management system) that the law mentions.
Waveland lawyers and Qase3D offer a complete well prepared policy and management platform.This prevents you from doing too much (like implementing a full ISO standard) and assures you of your provable legal compliance to the MDR legislation.We are happy to help you with our legal knowledge.
Back to Basics is in our DNA!” Complexity is always free with 3D printing.Whatever we do, it’s always going to be harder than what people have been doing for a 100 years.It’s always more complex to make custom devices than standard ones, and it’s always going to be harder to get people to do things differently.
In that context, the heavy lifting in the technology is what we should focus on.A simple tool that enables you to have easier compliance is therefore sorely needed.I wish more organizations would roll out similar tools globally to make the difficult path to compliance simpler everywhere.
Images courtesy of QasE3D
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