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More than a Quality Management System: Tools for the entire MedTech Lifecycle.

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Featured Capabilities:

Document Management Training Management Product Development Design Control Risk Management CAPA Management Audit Management

Experience the #1 QMS software for medical device companies first-hand. Click through an interactive demo.

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Data collection and management designed for MedTech clinical trials.

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Featured Capabilities:

Electronic Data Capture (EDC) Electronic Case Report Forms (eCRF) Electronic Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys Product Add-Ons

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Ultimate Guide to Comparing Quality Management System Solutions

This eBook compares the best QMS software solutions to help medical device companies make an informed decision when investing in a quality management system.

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FREE ON-DEMAND WEBINAR

The Power of 3D-Printed Medical Devices: Proven Regulatory Strategies & Quality Recommendations to Use for Additive Manufacturing

While additive manufacturing (a.k.a. 3D printing) is a forty-year-old process, many medical device firms struggle with determining whether or not it’s appropriate for them to use in making products, validating workflows, and executing compliance strategies.

Register for this free, in-depth webinar to learn from top experts in this field, Sam Murray and Gaurav Manchanda of Formlabs, as they discuss the various 3D printing technologies and how best-in-class medical device companies are utilizing them today, while also providing insights into the key considerations that should be evaluated when validating the workflow. 

Participants will be given actionable recommendations and the guidance to implement a successful quality management system that encompasses the nuances of the computer-aided design and manufacturing (CAD/CAM) process while also meeting all regulatory requirements necessary to successfully commercialize end-use 3D-printed medical devices.

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Specifically, this webinar will cover:
  • An evaluation of various manufacturing methods and 3D printing technologies
  • Considerations for QA/RA requirements and constraints, including ISO 13485, ISO 10993-1, 21 CFR 820, and EU MDR
  • Recommendations for QMS, design verification and validation, and process validation (IQ/OQ/PQ) while utilizing additive manufacturing for patient-specific or mass-market devices
  • Regulatory considerations for commercialization of 3D printed medical devices in Europe and the United States
  • Case studies to illustrate how 3D printing is used by medical device firms including R&D, manufacturing aids, premarket submissions, and final-use parts
Who Should Attend?
  • Medical Device Executives
  • R&D Engineers and Management
  • QA/RA Professionals and Management
  • Product Managers, Process Engineers, and Operations Managers
  • Med Device Development Professionals in North America and Europe
 Register Now  

Hosted by

Sam-Murray
Presenter: Sam Murray

Director of Regulatory Affairs and Quality Assurance, Formlabs 

Gaurav-Manchanda
Presenter: Gaurav Manchanda

Director of Medical Market Development, Formlabs

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Moderator: Etienne Nichols

Medical Device Guru, Greenlight Guru

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About Formlabs

Formlabs is expanding access to digital fabrication so that anyone can make anything. It has become the all-time best-selling 3D printer for professionals within ten years, with over 80,000 SLA and SLS machines sold, hundreds of thousands of surgeries supported, and over 70 million end-use medical supplies printed by customers in the last 18 months alone. By combining clinically validated 3D printing technology, in-house QA/RA services, and accessible pricing and user-friendliness, the company enables healthcare professionals and medical device engineers to enhance surgery, radiology, orthotics and prosthetics, device development, and device manufacturing. Formlabs has FDA-registered, ISO 13485-certified manufacturing facilities that it uses to produce a range of biocompatible, sterilizable materials. Its solutions have been used in hundreds of clinical publications and are trusted by the world’s leading health systems and medical device manufacturers. Visit their website to learn more.

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About Greenlight Guru

Greenlight Guru is the only Medical Device Success Platform (MDSP) for companies to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based software, Greenlight Guru is easier to implement, easier to use and designed to fit all medical device needs to enable innovative, safe and effective, True Quality medical devices. Visit our homepage to learn more.

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