REGISTER NOW FOR OUR FREE WEBINAR - APRIL 17, 2024; 1PM EST!
There have been many great strides surrounding the guidance for reprocessing (cleaning, disinfection, and/or sterilization) validations of reusable medical devices, such as AAMI ST98:2022 and recent updates to established standards like AAMI TIR12:2020 and ISO 15883-5:2021. It can be difficult to navigate these updates and ensure that your reusable devices have the proper reprocessing validation. In addition, there are still gaps in guidance that have led to “gray areas” of reprocessing. These gray areas include reprocessing validations for single-use devices provided non-sterile, reprocessing validations for novel reusable devices being used for clinical trials, reprocessing instructions for at-home devices, and wearable non-critical devices. While we can rely on published documents to provide guidance in these gray areas, there are questions that need addressing to ensure the safety of the devices associated with these situations.
Key Learning Points:
Nelson Labs is a global leader in microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries. We serve over 3,000 customers across 13 facilities in the United States, Mexico, Asia and Europe. With a comprehensive array of over 900 laboratory tests and the expertise of Regulatory Compliance Associates, a recognized leader in life science consulting, we support our customers from initial product development and sterilization validation, through regulatory approval and ongoing product testing for sterility, safety and quality assurance. We are regarded as a best-in-class partner with a strong track record of collaborating with customers to solve complex issues.
SPEAKERS:
Branna Barber - Consulting Study Director at Nelson Labs
Griffin Cammack - Expert Technical Consultant at Nelson Labs
Sean Fenske - Editor-In-Cheif of MPO & ODT
SPEAKERS:
Katlin Lumme
Director of Engineering, Porex
Sean Fenske
Editor-in-Cheif, MPO/ODT
Hear first-hand from Westminster Tool, a Connecticut-based toolmaker specializing in complex injection mold tooling for the medical device industry, on their additive journey and why they invested in a Mantle system. Westminster Tool will share case studies—with data—on how they are adding value with their Mantle system.
Speakers:
Hillary Thomas
Vice President, Westminster Tool
Sean Fenske
Editor-in-Chief, MPO/ODT
Focusing on the world of outsourcing for medical device manufacturing coupled with a keen awareness of innovation in the space, Medical Product Outsourcing’s conference series has provided the medtech industry with the most comprehensive programs for more than 15 years. These highly informative symposiums address critical issues impacting multiple stakeholders within the industry. In 2023, the MedDevice Forum—a medical device manufacturing conference event—will take place in San Jose, Costa Rica. Modeled after the industry leading MPO Summit, MedDevice Forum will offer a more intimate setting for attendees seeking solutions to industry challenges. Graciously hosted by the Costa Rica Marriott Hotel Hacienda Belen, this event will simultaneously highlight the appeal of the region for medtech while tackling a number of the most significant issues for today’s medical device companies.
Against the backdrop of such an impressive location, this interactive networking and educational event will partner local experts with out-of-state industry thought leaders—OEMs, contract manufacturers, suppliers, consultants, members of the investment community, and academia—for a unique forum to discuss critical industry topics and offer tools to compete and grow in today’s challenging business climate.
Ultra-fast lasers have transformed the industry and continue to grow capabilities in cutting edge, high-performance medical technologies while also improving cost efficiencies. This presentation will specifically focus on different laser processing techniques and how they can excel in different applications.
We will showcase how ultra-fast lasers can be used in a variety of high-precision medical products with different processing techniques. For instance, cutting stents out of bioresorbable polymers, create spiral patterns into liners, drill hole arrays in tubing and filters/spargers, drill features into implantable bone screws, selectively ablate the OD tubing, and even drill or cut features in medical balloons. We’ll also discuss how these techniques can bring cost efficiency and incredibly high-precision together to create a desirable service.
SPONSORED BY:
Spectrum’s history spans over 60 years of applications expertise including precision extrusion, specialty injection molding, blown film extrusion and conversion, medical balloon fabrication, laser processing, additive manufacturing, and complex assembly of catheters and other devices. Today, Spectrum is a leading full-service partner for the development and manufacturing of critical polymer-based components and finished devices for medical and other demanding applications. With 20 locations and over one million square feet of manufacturing space in six countries worldwide, we have the resources to solve customers’ most challenging problems with proven quality, responsiveness, innovation, and technical expertise.
PRESENTED BY:
SPEAKERS:
Trevor Vincent
Applications Engineer – Interventional & Surgical Technologies
Spectrum Plastics Group