MasterControl Inc. provides cloud-based software to empower manufacturers in life sciences and other regulated industries simplify manufacturing execution. Our mission is to help our customers bring life-changing products to more people sooner. Learn how to take a smarter approach to manufacturing at mastercontrol.com.
The Voluntary Improvement Program (VIP) helps device makers design, build and deliver safer products to patients, faster. Developed in collaboration with FDA, MDIC, ISACA and the medical device industry as part of the FDA’s case for quality initiative, this program identifies process inefficiencies and helps device makers implement best practices that accelerate medical device improvements. Participant outcomes include increased speed to market, improved production capacity, reduced regulatory burden & more.
Eligible participants also benefit from several FDA opportunities to help accelerate improvements to device quality and manufacturing by means of modified inspection planning and bundled PMA and Site Change submissions with reduced review timeframes, all detailed in the FDA Guidance “Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program” released in September 2023.
Compliance Architects LLC delivers high-value compliance, quality, and regulatory consulting services to companies directly regulated by the U.S. FDA and other global regulatory authorities. With capabilities ranging from quality systems implementations to audits, inspection readiness, enforcement remediation, and outsourced compliance services, Compliance Architects LLC has the experience, expertise, and delivery capability to significantly improve your company’s business outcomes. Jack Garvey is CA’s founder and CEO, a chemical engineer and a practicing regulatory attorney, and has spent his entire career helping companies navigate the challenges at the intersections of science, engineering, business, and law.
WE ENGINEER CONFIDENCE
From discovery to delivery, the world’s leading medtech companies trust Phillips Medisize to help them engineer and produce custom medical device components and finished devices – from continuous glucose monitors and insulin pumps for diabetic patients to complex cables and interconnect solutions for electrophysiology and intravascular ultrasound catheters and much, much more. Our company, in collaboration with our parent company Molex, offers worldclass electronics and contract development and manufacturing organization (CDMO) capabilities to medical device companies of all sizes. Leveraging our 60 years of experience, our engineers can help your team launch life-enhancing and lifesaving products on time.
Our exceptional CDMO services and proven Molex connectivity solutions include:
Advanced injection molding with complex assembly and integration of electronic components for subassemblies and finished devices
Interconnects with custom complex cable assembly
Custom connectors
Fiber optics solutions
Honeywell Life Sciences, the makers of TrackWise, are on a mission to accelerate innovation for a healthier future. From manufacturing life-saving drugs to safeguarding supply chain continuity, Life Sciences organizations partner with Honeywell to solve their most critical challenges and drive meaningful patient and business outcomes. Honeywell empower Life Science companies with the latest innovation to improve operational efficiency and bring safer products to market faster, by automating and optimizing their manufacturing and supply chain eco-system. Life Sciences companies worldwide trust Honeywell for the advanced technology solutions and domain expertise they need to drive continuous business improvements while helping them make smarter faster decisions about the things that matter most.
Premier Inc. (NASDAQ: PINC) is a leading healthcare improvement company, uniting an alliance of more than 4,350 U.S. hospitals and health systems and approximately 325,000 other providers and organizations to transform healthcare. With integrated data and analytics, collaboratives, supply chain solutions, and consulting and other services, Premier enables better care and outcomes at a lower cost. Premier plays a critical role in the rapidly evolving healthcare industry, collaborating with members to co-develop long-term innovations that reinvent and improve the way care is delivered to patients nationwide. Headquartered in Charlotte, NC, Premier is passionate about transforming American healthcare.
Regenity Biosciences, a Linden Capital Partners portfolio company, is a leading global developer and manufacturer of bioresorbable technologies to repair and regenerate natural tissue and bone for a variety of markets including dental, spine, orthopedic, sports medicine, advanced wound, neurosurgery, ENT, and nerve repair. Founded in 1997, Regenity (formerly Collagen Matrix, Inc.) is headquartered in Paramus, New Jersey, with manufacturing locations in Oakland and Allendale, New Jersey and Groningen, the Netherlands. Regenity’s product portfolio includes a variety of collagen-based and synthetic polymer solutions that support the company’s platform for tissue and bone regeneration. Regenity develops proprietary products that are sold to OEM customers on either a contract or private label basis and offers partnership opportunities including contract product development and manufacturing services. For more information, please visit www.regenity.com.
Veeva MedTech is a division of Veeva Systems, the global leader in cloud software for the life sciences industry. Committed to innovation, product excellence, and customer success, Veeva serves more than 1,000 customers, ranging from the world’s largest biopharmaceutical and medtech companies to emerging biotechs. As a Public Benefit Corporation, Veeva is committed to balancing the interests of all stakeholders, including customers, employees, shareholders, and the industries it serves. For more information, visit veeva.com/medtech.
ChiAha’s Prediction Toolkit Can Help You Answer Your Factory Flow Questions.
ChiAha can predict production line performance and OEE within 1% accuracy using high fidelity data-driven behavior.
Get objective answers, at lightning speed, to many of your strategic questions related to the design, operation and improvement of high speed production.
Let Chiaha help you accelerate your “raw data to prediction” journey!
Lumafield was founded in 2019 to upgrade manufacturing. We are engineers with deep experience across the product development cycle, from initial ideas to shipping hardware, across industries and specializations, who became frustrated by the cost and complexity of modern manufacturing. So we decided to upgrade it.
Medical Engineering Consultants is the premier solutions provider for manufacturers and developers in the medical device, pharmaceutical, and biotechnology industries. As an internationally recognized leader, our subject matter experts are always ready to take on projects of any size or scope. MEC is proud to be the vehicle for creating positive change in our industry.
TrueContext, formerly ProntoForms, is the global leader in mobile forms, workflows, and data collection. We help medical device manufacturers rise to the complexity of field service using adaptive workflows, empowering them to know more, do more, and be more. Over 100,000 users trust our connected, adaptive workflows to streamline and inform field service and collect actionable insights across all levels of operation – all in real time.
ChiAha’s Prediction Toolkit Can Help You Answer Your Factory Flow Questions.
ChiAha can predict production line performance and OEE within 1% accuracy using high fidelity data-driven behavior.
Get objective answers, at lightning speed, to many of your strategic questions related to the design, operation and improvement of high speed production.
Let Chiaha help you accelerate your “raw data to prediction” journey!
Emerson is a global leader in automation technology and industrial software, providing innovative solutions that help life sciences manufacturers optimize operations, enhance efficiency, and ensure regulatory compliance. With a focus on digital transformation, Emerson enables smarter, data-driven decision-making to drive productivity, quality, and sustainable growth in highly regulated industries.
Honeywell Life Sciences, the makers of TrackWise, are on a mission to accelerate innovation for a healthier future. From manufacturing life-saving drugs to safeguarding supply chain continuity, Life Sciences organizations partner with Honeywell to solve their most critical challenges and drive meaningful patient and business outcomes. Honeywell empower Life Science companies with the latest innovation to improve operational efficiency and bring safer products to market faster, by automating and optimizing their manufacturing and supply chain eco-system. Life Sciences companies worldwide trust Honeywell for the advanced technology solutions and domain expertise they need to drive continuous business improvements while helping them make smarter faster decisions about the things that matter most.
IDA Ireland was founded in 1949 as the Irish Government agency responsible for the attraction and retention of foreign direct investment (FDI) into Ireland. IDA Ireland partners with multinational companies to attract investment, providing jobs for the economic and social benefit of Ireland.
We have partnered with 1,200 companies to establish operations in Ireland, including all the World’s Top 10 Biopharmaceutical companies.
The biopharmaceutical industry has made a capital investment of approximately $10 billion in new facilities in Ireland, most of which has come in the last 10 years. This represents the biggest wave of investment in new biotech facilities anywhere in the world.
Speak with us and you will soon understand why Ireland has developed Europe’s premier biopharma manufacturing cluster.
Jabil is a global manufacturing company with more than 140,000 employees across 100 locations in 25 countries. Jabil is the largest global provider of healthcare manufacturing solutions in the industry. Why does it matter that we are the largest provider of healthcare manufacturing solutions? Our customers benefit from decades of experience and an unmatched array of design, engineering, supply chain, process development, and production solutions across the healthcare landscape. To every product line, we apply our experience and proven, refined processes so you can be assured that your products are in good hands.
Our operating model is unique in healthcare manufacturing, and it features teams centered on each customer account (or “Business Unit”) to ensure deep domain expertise, close collaboration, and project prioritization. Jabil operates with consistent operations systems, processes, and quality programs across our locations around the world, making it easier to transfer and launch manufacturing programs across our global network of sites.