In the face of increased quality issues and the high costs of maintaining compliance, Medical Devices organizations face significant challenges in advancing product quality and still meeting the demands of growing the bottom line and overall business profitability. These challenges are present across various phases of the product development life-cycle including planning, design, supply, manufacturing, and customer support. Most often resolution of the issues presenting are approached in technology silos resulting in islands of automation and disjoint information systems, which are neither optimized for the users nor provide optimum functionality for the business process.
CXV Global is an ideal partner to help Medical Device manufacturers design and develop products that meet industry connectivity and interoperability requirements and standards. Our solutions comprise of design, hardware, software, support and training services and provide compliance with industry regulations including FDA CFR 21 Part 11 and GAMP standards. Our solutions and services are geared towards reducing development costs, improving time to market, and reducing the barriers to market entry.
Using patent pending technology to reduce line changeover times is the single greatest potential for improving line availability: entire shifts worth of availability can be unlocked by deploying a machine vision system that conducts inspections in milliseconds that would normally take operators minutes.
The CXV Global SmartFactory LineClearance Assistant (LCA) is a machine vision system which assesses the line clearance during line changeovers through objective electronic decisions that are quicker to achieve and repeatable when compared with manual line clearance procedures.
CXV Global are experts in machine vision for medical device applications with over 30 years’ experience with leading FDA-approved device manufacturers for whom we verify millions of parts daily.
Among critical in-process quality control technologies, none gives greater certainty to medical device manufacturers than machine vision. High-resolution cameras capture evidence of in-process checks; perform minute inspections on dimensions, counts and text; and verify that a device has been manufactured, assembled, packed and labelled correctly every time.
CXV Global provides a specific engineering resource, or alternatively, a cross-functional engineering team.
Managed Service Provision
Insource CXV Global expertise to take responsibility for productivity, compliance and quality while operating under client SOPs, KPIs and final approval. The client has visibility and control as CXV Global staff carry out the work.
Functional Service Provision
CXV Global manage the delivery of a function to the pharmaceutical manufacturer customer using CXV Global people to deliver and manage the agreed customers goals. You the customer own the assets – CXV Global fully manages them for you.
The production and distribution of medical devices is highly regulated. Driven by patient safety, vision inspection is employed widely throughout the manufacturing to guarantee product quality, reduce recalls and comply with regulations around traceability, namely the Unique Device Identification (UDI).
We’ve been leading the way in the solutions we bring to customer problems and in the deployment of leading edge technologies for over 30 years.