Solutions for Medical Equipment Manufacturers
Partnered Services for medical equipment Manufacturers & Distributors
Partnered Equipment Services
Compliance & Validation
FDA Product Recall Management
Partnered Equipment ServicesSolutions that help Medical Equipment Manufacturers & Dealers create loyal customers and increase profitability
However, the challenges that many companies face that want to drive growth in services is the amount of time, money and resources required to effectively operate a growing service business. CSA’s customer focused approach uses the power of talented people, efficient processes, in depth analytics and the latest technologies to help our clients cost effectively address these challenges and significantly enhance service revenue growth and customer satisfaction. Our Partnered Equipment Services provide our clients with a complete end to end service delivery solution or a customized solution to complement their existing service resources.
Why Partner With CSA?
We have years of experience supporting healthcare technology and understand requirement of working in healthcare environments. We provide medical equipment maintenance and repair on most equipment types and modalities. Our field service engineers are very familiar with the healthcare environment and the procedures that are required by many healthcare institutions such as proper check-in, vendor credentialing and HIPPA. They receive all the safety training required to work in hospitals or clinics where there's potential exposure to blood-born pathogens. They're also equipped with the necessary test equipment including electrical leakage testers, patient simulators and imaging phantoms.
We’ve streamlined the complete service delivery process and incorporate all aspect of technical service operations and field service delivery to provide the most complete service outsourcing solution in the industry. Over the past 18 years, we have managed critical service delivery processes on our clients’ behalf with a commitment to operational excellence, innovation and world-class customer service.
Our nationwide service organization can leverage the backing of more resources and more experience to streamline the delivery of quality support services. Our service operations infrastructure and service delivery processes have been continually refined over years, across multiple industries. We understand the emerging service delivery trends and emerging technology that is necessary for the efficient delivery of quality technical services. When we identify efficiencies or process improvements that can lower costs, we act.
Growth that is maintainable and profitable is what most businesses are pursuing. And the opportunities for growth in the medical device and equipment industry are clear. As a service delivery partner, we establish a continuous improvement communication loop with each of our clients to communicate results, hone our deliverables and proactively prepare for future needs. We work with our clients to establish a clear roadmap so we are prepared to scale quickly and effectively.
Every client’s needs are unique. We provide flexible customized solutions based on our client’s needs and business objectives. We can complement your existing service resources or provide a complete service operations outsourcing solution. We provide a flexible managed solution, therefore it can be deployed for a one-time engagement or an ongoing partnership. We have the largest dedicated implementation team in our industry. We manage successful implementations by clearly understanding our customers’ needs, challenges, and requirements prior to designing the processes.
Quality is at the heart of all our operations. Whether it is a recall for a medical device or regular maintenance, our clients rely on us to deliver the best quality talent and services. We’ve invested in and operate on state-of-the-art service management, logistics, training and quality systems. Our quality system incorporates efficient workflow processes to ensure that all CSA associates are equipped to consistently deliver quality.
The key to growing a successful business over the long term is customer loyalty. Without loyal customers a business will eventually wither away and die. Great products can create customers, but it's excellent service that creates loyal customers. We're experts at delivering high quality service solutions that create and maintain customer loyalty. Our Customer Centric Service Delivery Model serves as the foundation of our ability to consistently deliver excellent service at an affordable price.
Some businesses treat service as a necessary evil and the cost of doing business. They view service as a cost center. However, we see service as a profit center that, if done right, can generate revenue and create loyal customers. We've helped many companies use service as a strategic growth engine that ensures long term business growth. We provide expert consultation and guidance to help our clients make this transformation.
It takes a significant investment for a business to create its' own service organization. And along with the investment comes a lot responsibility, hassle and financial risk due fluctuating cost and workload demand. Our fixed pricing model enables our clients to know their service delivery cost down to the penny. Being able to accurately predict service delivery cost results in simplified budgeting, predictable margins and elimination of all the risk.
Clinical Education ServicesA Proven Partner for Providing Clinical Applications Training & Support
CSA Clinical Solutions add value and staffing flexibility to medical device & equipment manufacturers, dealers and re-sellers with our professional Clinical Educators located across the country. We have a proven record of accomplishment in recruiting, training, and retaining resources. We offer per-diem and contracted resources so you can control your baseline staffing overhead and customer or patient education costs. We offer flexible solutions that can be customized to meet your contract needs.
Expertise You Can Count
Our Clinical Educators consist of critical care registered nurses, radiologic technologists, sonographers and respiratory therapists that bring instant credibility to your product life-cycle needs or staffing requirements. These clinicians make us proud everyday with their tremendous knowledge, expertise, customer focus, and flexibility. If your needs involve Clinical Educators in other care environments or disciplines, we can meet those requirements too.
Our nationwide team is strategically located across the country. They all have experience providing clinical application support for most healthcare modalities, including critical care (EDs, ICUs, ORs, and NICUs), diagnostic imaging, diagnostic cardiology and more. We provide end-user and/or super-user education, create and change device configuration, and offer go-live support on medical devices. Our Clinical Educators are not the average bedside nurse because the products they support have a high technical learning curve. All educators are located in metropolitan areas for cost effective and efficient travel. In addition, all of them complete a thorough CSA and vendor orientation; which includes all education modules needed for vendor credentialing.
Modalities We Support
We are able to assume all of your clinical support needs, augment your full-time staff, or work side-by-side with other subcontractors to ensure you can stay focused on your business and your customers.
Compliance & Validation ServicesExpert FDA regulatory services for medical equipment & software compliance
Medical Equipment Process Validation
Domestic and international regulators require medical products to be produced in a manner that is safe, effective and compliant with GMP requirements. To help enforce this, regulatory bodies such as the US FDA, and international standards such as ISO 13485 have long required that processes be validated if the output cannot be fully verified through post production testing This is even more important than ever since most new medical technologies are simply too complex for this approach. Over the last few years, FDA inspectors have been placing a much greater emphasis on medical device process validation even for suppliers. In fact, the number of warning letters issued to equipment manufacturers containing process validation issues has jumped over 270% since 2007. Yet many companies continue to ignore these requirements or fail to leverage their benefit until it is too late. Putting off validation until you receive a 483 or warning letter can be disruptive, time consuming and costly. Its more important than ever to build compliance into your processes early.
Process Validation and Risk Management
ISO 14971 illustrates the strong relationship between validated processes and product risk management. When implemented correctly, process validation reaches across the entire operation to ensure that product requirements are adequately addressed. This holistic approach incorporates all the components of the process – including equipment, software, utilities, and others – as well as the overall operation to insure each performs and interacts as intended in the production of high quality products. Just as designers must validate a device’s use to specifications, manufacturers must validate a process’s ability to be produce to specifications.
Although each is unique, product and process development go hand-in-hand. That’s why successful process validation projects leverage the knowledge of product development engineers, healthcare providers and regulatory compliance specialists as well as manufacturing and quality teams to define and test critical process steps.
Medical Equipment Production
CSA can help validate your medical equipment manufacturing processes by analyzing the requirements critical to process performance. Our risk managed approach not only speeds up the validation process and reduces testing, but also provides valuable insight that can be used for process optimization and control.
Our experts can help you define your critical processes and implement a validation solution that meets your exact needs. Our experience includes many types of process technologies including those used in:
FDA Product Recall Management SolutionsProfessional Recall Support Solutions for Medical Equipment Manufacturers
Facing a FDA Product Recall? CSA Can Help!
FDA product recalls impact hundreds of manufacturers every year. The impact of a recall can cause devastating effects on a manufacturer's finances and reputation resulting in loss of sales, delayed product delivery and damaged customer relationships. Without the adequate resources, expertise and systems in place, a recall can cause irreversible brand damage and revenue loss. Navigating through recall process maze can overwhelming and puts tremendous strain on an organization's resources.
CSA's FDA Recall Management Solutions provides you with the expertise and resources to efficiently manage a recall from start to finish. We customize our solutions based on your requirements and keep you and your customers informed throughout every step of the recall process. We work with you to create and execute a well thought-out, comprehensive roadmap which includes planning, preparation, execution and closeout with regulatory agencies.
What differentiates CSA from other FDA regulatory consulting agencies is the comprehensive resources that we provide. In addition to our FDA regulatory experience and expertise, we have all the resources in place to rapidly and cost effectively execute the recall plan. These resources include a nationwide team of professional field service engineers and clinical educators to implement on-site product updates and training. Our team of professionals have the skills, experience and tools to quickly resolve the product issue and alleviate any customer anxiety resulting in a positive experience for your customers.
Our Recall Management Solution Includes:
Planning & Consulting
Centralized Recall Management
Compliance and Regulatory Reporting
FDA Action Remediation