“You Work Hard, Your Products Should Too”
Day in, day out, you take on the roles and responsibilities as a vital member of your health care system. By doing so, you are providing crucial services for every hospital department, ensuring that the hospital is supported. More recently, you have worked tirelessly helping our country fight through this COVID-19 pandemic. For this we thank you! But you already know the hard work you do. Elite Biomedical Solutions believes your purchased products and services should uphold the same high standards, high quality and reliability. As your business partner here are our commitments to you.
High Quality Standards
We believe that quality cannot have shortcuts. Because of this, Elite Biomedical Solutions takes a risk management approach for our products and services. The risk management process includes many steps. Such as identifying the risk, assessing the likelihood of the risk occurring, impact of this risk, implementing risk mitigation strategies and monitoring the effectiveness of the risk management controls. The results of the risk management process allow Elite to anticipate any error and to minimize the impact. The best result of an effective risk management process is prevention.
Elite also completes risk evaluations. During this, each risk is evaluated for the probability (likelihood) of it happening and the consequences. These two factors help determine if said risk is considered high, medium or low. By performing a risk evaluation, Elite can focus on any and all risks that impact the patient’s safety.
After risks are evaluated and prioritized, we decide to either accept, reduce or eliminate each risk. Risks may be reduced or eliminated by introducing new gauging, new fixture equipment, poka yokes or by altering the production/assembly process. Once the Elite team evaluates the risk mitigation plan, these plans are put in place. Risk Management is not a one-time exercise. Continuous monitoring and reviewing are crucial for effective risk management.
Furthermore, Elite Biomedical Solutions is a registered ISO 13485:2016 and ISO 9001:2015 company. Annual audits are completed by an outside ANAB accredited registrar. Just as important as the registrar audit, is the ongoing internal auditing plan. Elite has several internal auditors who also audit our processes. These audits are completed to ensure conformance to the ISO standards and operating procedures. Elite is also FDA registered and complies with 21CFR820, Quality System Regulation.
USA Manufacturing Control
Now, more than ever, the health care industry lacks domestic sourcing. Elite has set out to become just that. We strongly believe you should know and trust your sources. Therefore, years ago we began the journey of in-house manufacturing. Throughout those years we have invested in the proper tooling, highly trained experts and custom materials to provide you with high-quality manufacturing.
With this goal in mind, Elite regularly evaluates its processes for improvement. We are firm believers in continual improvement. It is an ongoing effort to advance our processes, products and services in order to provide the best solution. Our team works closely with you to exchange ideas and brainstorm improvements. Through the plan, do, check, act (PDCA) cycle, these ideas or solutions are tried and tested. If proven effective, they are then implemented.
Design Control
Throughout the entire process of product development, we follow a strict set of guidelines. This is accomplished by establishing a detailed project plan from the collaboration of department design reviews. The reviews foster input and discussion on the product design and the areas with special consideration. Documentation is created and maintained for each design review. Every product process is validated through an IQ, OQ and PQ process to ensure that the respective process will yield a product that meets the predetermined requirements. This is true regardless of how complicated or simple the process is.
Prior to releasing a product for sale, a test protocol is created and performed to ensure that Elite parts perform to the same level as OEM. Each product is composed of numerous parts that are either fastened together or included in assembly. A detailed set of assembly steps are created and validated to guarantee the assembly is correct and contains all components.
Peace of Mind
From the start, we made a commitment to high-quality, USA-manufactured products. Over the years we have put in the work, hired the talent and streamlined our processes to accomplish this. Because of our higher standards, we can effectively reduce the risks for your business in environmental, financial, regulatory and safety terms. By bringing manufacturing back to the U.S., you are creating jobs for Americans and securing the U.S. supply chain of needed products. Whether you are a biomed, hospital management or working within the health care industry, your products should work as hard as you. Our goal is to design, manufacture and build products that allow you to keep doing what you do best.
For more information visit elitebiomedicalsolutions.com.
