MED Institute Inc. supports developers of medical products through the start of an idea and making a product available to clinicians and patients. With more than 30 years of medical device testing and global regulatory submissions experience, the company knows what it takes to guide a product through the steps for market approval.
Ketryx
Ketryx is an end-to-end validated software development and deployment framework that empowers regulated software teams to develop fast and stay compliant. Designed to increase developer productivity and reduce quality overhead, Ketryx integrates all of your team’s preferred development tools like Jira or GitHub into a single, traceable Software Development Lifecycle, turning regular developers into regulated developers with no disruption to daily activities. | .
Kaleidoscope Innovation
Kaleidoscope Innovation, an Infosys company headquartered in Cincinnati, Ohio, provides end-to-end product development and consulting services that bring ideas to next-level success. For more than 36 years, we’ve partnered with clients to design intuitive products and experiences that are seamless extensions of the people who use them.Our multidisciplinary team—spanning insights, design, human factors, and engineering—thrives at the intersection of creativity and technical precision. From concept to commercialization, we help clients solve complex challenges, improve outcomes, and create meaningful impact across industries.Whether building tools that save lives, products that enhance everyday experiences, or systems that improve efficiency, we’re driven by one goal: to enhance people’s lives.Imagine what we can do together.Learn more at kascope.com.
Informa / SPMC Blood Drive
The Sterilization Packaging Manufacturers Council (SPMC) is celebrating Sterile Packaging Day at MD&M West on February 4 by holding the Informa + SPMC Red Cross Blood Drive in Hall E, Booth 175. Attendees are encouraged to donate blood. Our goal is to fill every slot available. Sign up here. Sterile Packaging Day was founded by the SPMC in 2021 to recognize the vital role sterile packaging plays in patient safety. It’s a day when the entire healthcare packaging community comes together to pause and appreciate the materials, designs, and people that make sterility possible.
Hohenstein Medical
Hohenstein Medical is a global, best-in-class GLP-certified and ISO/IEC 17025-accredited laboratory, conducting biocompatibility testing for medical devices, including analytical chemical characterization assays, biological in-vitro tests and microbiological evaluations. Hohenstein is one of the few laboratories accredited in chemical, physical and biological testing—offering an integrated approach to medical product evaluation. This full-scope capability provides manufacturers peace of mind with consistent, efficient studies aligned with the U.S. FDA, EU MDR, ISO-10993 and other regulatory requirements. Hohenstein Medical works with medical device and raw materials, offering comprehensive testing services, including single-use and reusable, finished devices and components, patient-contact and protective equipment — all tailored to the intended use, classification and regulatory pathway. The team collaborates with clients to customize study designs when standard methods are not sufficient. Hohenstein Medical is a division of Hohenstein Laboratories, a leading provider of independent testing, research and certification with more than 75 years of scientific experience.
Grand Avenue Software
Grand Avenue Software provides the industry-leading quality management software solution for medical product companies. We are the affordable, scalable, and efficient quality compliant eQMS deployed by med-tech innovators and leaders around the world in business 20+ years. Our team has extensive experience in software development, Software as a Service (SaaS) delivery, and quality compliance, specifically for the life sciences industries. We work hand-in-hand with startups, emerging growth and established companies to navigate the complex regulatory affairs (RA) and quality assurance (QA) environment. With Grand Avenue Software, compliance is assured, your budget is preserved.
EVERGEN
We are a world-class Contract Development and Manufacturing Organization (CDMO) driven by a patient-first approach to innovation. Starting from the patient need, we partner with Original Equipment Manufacturers (OEMs) to develop and deliver customized regenerative biomaterial solutions with a goal to promote healing, accelerate recovery, and help prevent complications to enhance patient lives. | Evergen is a leading Contract Development and Manufacturing Organization (CDMO) pushing the boundaries of innovation and tissue engineering to meet patient needs in regenerative medicine. We are expert partners to Original Equipment Manufacturers (OEMs), working with them to identify clinical problems and develop customized solutions that promote healing, accelerate recovery, and help prevent complications. Using our extensive portfolio of biological materials, we focus on specialized clinical segments, including plastic and reconstructive surgery, sports medicine and orthopedics, cardiac, and neurosurgery. | Evergen is a leading Contract Development and Manufacturing Organization (CDMO) pushing the boundaries of innovation and tissue engineering to meet patient needs in regenerative medicine. We are expert partners to Original Equipment Manufacturers (OEMs), working with them to identify clinical problems and develop customized solutions that promote healing, accelerate recovery, and help prevent complications. Using our extensive portfolio of biological materials, we focus on specialized clinical segments, including plastic and reconstructive surgery, sports medicine and orthopedics, cardiac, and neurosurgery. Headquartered in Alachua, Florida, Evergen has facilities in the United States, Europe and New Zealand. For more information, visit www.evergenbio.com. | We are a world-class Contract Development and Manufacturing Organization (CDMO) driven by a patient-first approach to innovation. Starting from the patient’s needs, we partner with Original Equipment Manufacturers (OEMs) to develop and deliver customized regenerative biomaterial solutions with a goal to promote healing, accelerate recovery, and help prevent complications to enhance patient lives.
EPflex Feinwerktechnik GmbH
EPflex is one of the world’s leading OEM manufacturers of components for minimally invasive medicine. With numerous patents and innovations, we are among the pioneers in the industry and push the boundaries of minimally invasive surgery every day. For patients, this means shorter procedures, less pain and faster recovery. OUR PRODUCTS & SERVICES: Guidewires ⸱ Stone Retrieval Devices (Baskets & Graspers) ⸱ Hypo Tubes ⸱ Slings ⸱ Stylets ⸱ Dispensers ⸱ Packaging ⸱ Special Products
Enlil
Enlil is a cutting-edge development traceability platform designed to accelerate regulated product innovation from ideation to commercialization. As a comprehensive QMS++ solution, Enlil offers a broad range of modular capabilities, including QMS, PLM, procurement, engineering builds, MES, lot management, asset management, traceability, and content collaboration—providing a seamless digital thread for every stage of product development.Affordable, scalable, and quick to deploy, Enlil’s SaaS platform is purpose-built to support OEMs, innovation hubs, contract manufacturers, and product design-regulated product innovators as they grow from early-stage startups to multi-team organizations. | Enlil enables MedTech incubators and product companies to ideate, build, and commercialize their regulated innovations faster. With a single platform unifying Quality Management System (QMS), Product Lifecycle Management (PLM), Manufacturing Execution System (MES), Enterprise Resource Planning (ERP), and requirements management capabilities, Enlil creates a seamless digital thread from product conception through its design, validation, launch, and post-market stages. Our SaaS cloud-based solution delivers a robust, scalable framework, empowering early-stage startups and expanding mid-market enterprises to realize the benefits of digital acceleration by offering a single source of truth throughout the product lifecycle, and end-to-end hardware, software, and document traceability from prototyping and production to inventory and distribution. Enlil is a portfolio company of Shifamed, a MedTech innovation hub in Silicon Valley with a long history of success in founding cutting-edge medical device companies and bringing breakthrough products to market. | Enlil is a cutting-edge development traceability platform designed to accelerate regulated product innovation from ideation to commercialization. As a comprehensive QMS++ solution, Enlil offers a broad range of modular capabilities, including QMS, PLM, procurement, engineering builds, MES, lot management, asset management, traceability, and content collaboration—providing a seamless digital thread for every stage of product development.Affordable, scalable, and quick to deploy, Enlil’s SaaS platform is purpose-built to support OEMs, innovation hubs, contract manufacturers, and product design regulated product innovators as they grow from early-stage startups to multi-team organizations.