Nemko USA provides quality system certifications for ISO 9001, ISO 13485, ISO 27001 and MDSAP in addition to its EMC, product safety, wireless testing, precompliance, and certification services. Certifications also include CE marking (MDD), CB, and FCC.
MasterControl Inc.
MasterControl Inc. is a leading provider of cloud-based quality and manufacturing software for life sciences and other regulated industries. For three decades, our mission has been the same as that of our customers – to bring life-changing products to more people sooner. MasterControl helps organizations digitize, automate, and connect quality and manufacturing processes. Innovative MasterControl tools have a proven track record of improving product quality, reducing cost, and accelerating time to market. Over 1,100 companies worldwide use MasterControl solutions to streamline operations, maintain compliance, easily analyze and interpret large amounts of data, and visualize business insights in real time. For more information, visit www.mastercontrol.com. | MasterControl Inc. provides AI enhanced, cloud-based software to regulated industries. Quality Excellence is simply the #1 QMS in life sciences. Manufacturing Excellence is a modern MES that slashes errors and boosts throughput. Asset Excellence automates asset maintenance and calibration. Combine them to get your products to market faster. Learn how at mastercontrol.com. | MasterControl Inc. provides AI enhanced, cloud-based software that empowers life science companies to improve quality and simplify manufacturing execution. Our mission is to help our customers bring life-changing products to more people sooner. Quality Excellence is the most trusted, connected, intelligent, and dynamic quality management system (QMS) in life sciences. Manufacturing Excellence is a modern MES designed to reduce errors, boost throughput, and simplify manufacturing execution. Asset Excellence is our latest innovation to help companies automate asset maintenance and calibration. Combining these solutions delivers the tools to virtually eliminate human errors and get your products to market faster. Learn how at mastercontrol.com.
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.
Dot Compliance Inc.
Founded in 2015, Dot Compliance provides a ready-to-deploy, Salesforce-native eQMS with the industry’s first AI specifically built to deliver safe, reliable decision guidance for critical quality issues. This offers faster, more proactive quality and compliance through vertical AI that empowers data-driven decision making in life sciences quality and compliance. The company’s solutions are trusted by life sciences companies, both large and small, worldwide. Dot Compliance is certified with ISO/IEC 42001:2023, ISO 9001:2015, ISO 27001:2022 and ISO 27017:2015. All solutions are fully compliant with 21 CFR Part 11, 21 CFR Part 820, EU Annex 11 and support ISO 13485 and ISO 14971. For more information, visit www.dotcompliance.com.
Crane Medtech Partners
What We DoMany medtech startups run into costly mistakes and delays. Innovation is full of promise, but moving from prototype to a clinically ready, regulatory-compliant product can be complicated, and confusing.We help medtech startups navigate this transition through fractional leadership support along with structure and tools, including clear roadmaps and practical templates, allowing teams to move forward efficiently and with confidence.What We OfferAdvisory and Fractional Quality leadership servicesQuick Start QMS Packages – ready to use, affordable, and scalableOn-demand audit services, gap assessments, and supplier evaluations
ComplianceQuest
Over the last decade, ComplianceQuest has revolutionized organizational dynamics by enhancing culture, collaboration, competency, efficiency, performance, and innovation. Leveraging AI-driven digital transformations in product lifecycle, quality, safety, supplier relationship management and compliance, our 100% Salesforce-powered cloud solutions have been pivotal. Standing as the premier platform, ComplianceQuest uniquely automates compliance operations with an integrated PLM, QMS, SRM and EHS framework. Our intelligent, data-driven approach mitigates risks, safeguarding employees, suppliers, and brand reputation while fostering innovation, compliance, profitability, and customer loyalty. Pre-validated and user-friendly, ComplianceQuest ensures seamless implementation, utilization, and maintenance, facilitating streamlined communication and collaboration throughout the product value chain. | Transform into a fully connected business with a next generation AI powered Product Lifecycle, Quality, Safety, and Supplier Management platform built on Salesforce.Our connected suite of solutions helps businesses of all sizes increase quality, safety, and efficiency as they bring their products from concept to customer success. Our intelligentdata driven platform comes with best in class integrated processes to mitigate risks, protect employees and customers, and strengthen brand reputation.ComplianceQuest is pre validated and easy to implement, easy to use, and easy to maintain. It enables streamlined communication, collaboration, and continuous improvementacross the entire value chain.
Chan-Way Precision Industry Co., Ltd.
CHAN WAY PRECISION INDUSTRY CO.,LTD was founded in Taipei Couty, Taiwan in 1997. In the field of precision parts processing, it has gradually developed to provide one-stop OEM services. We can provide professional mold design services, oem stamping, plastic injection molding, custom cnc machining, parts manufacturing, mold trial, mass production, and customized automation equipment import services. We offer mold design and manufacturing services in more than 20 countries around the world.
Allied Cleanrooms
At Allied Cleanrooms, we design, manufacture, and install state-of-the-art modular cleanroom systems for highly regulated industries. With over 35 years of experience, our U.S.-based team delivers turnkey modular cleanrooms that comply with ISO, cGMP, USP 797/800, and other standards.We can guide you from the initial concept all the way to installation and certification, and we are committed to building fully functional controlled environments that exceed expectations.