Products Reflecting Integrity Dedication and Excellence

At Excel Medical Products, we maintain the highest commitment to product and service quality, and full regulatory compliance. We are devoted to achieving continuous quality improvement to provide exceptional value and exceed the expectations of our customers. We implement controls throughout the product realization process to assure that purchased and manufactured product meets defined specifications, and that finished product is safe and effective for use.

We are an FDA registered and ISO 13485 certified medical device OEM and contract manufacturer. All employees of Excel are trained in accordance with Good Manufacturing Practices, and each day they demonstrate their dedication to product quality. From machine operators to upper management, all employees understand and play critical roles in ensuring product quality and safety.

Key Features of Our Quality System


Training

We believe that human resources are the most valuable resources available to our business. We invest a great deal of time and resources to ensure that our employees are thoroughly trained and qualified to perform their tasks. Our goal is to meet or exceed requirements and expectations; the first time, every time.

Auditing

Our quality management system is routinely audited to verify compliance with all applicable standards, regulations, and procedures. We welcome customer audits and we perform regular internal audits to ensure compliance. This proactive approach allows us to uncover potential issues so that we can prevent them from becoming problems.

Training

We believe that human resources are the most valuable resources available to our business. We invest a great deal of time and resources to ensure that our employees are thoroughly trained and qualified to perform their tasks. Our goal is to meet or exceed requirements and expectations; the first time, every time.

Auditing

Our quality management system is routinely audited to verify compliance with all applicable standards, regulations, and procedures. We welcome customer audits and we perform regular internal audits to ensure compliance. This proactive approach allows us to uncover potential issues so that we can prevent them from becoming problems.

Supplier Controls

To ensure the quality of all components and raw materials, we maintain a robust supplier qualification and management system. All prospective suppliers are thoroughly screened and evaluated to establish confidence that they can meet requirements of the goods and services they provide. All suppliers are routinely evaluated for their performance in providing goods and services that conform to specifications in a timely manner. We are diligent in proactively addressing potential supplier quality issues to prevent them from affecting the quality of the finished product. Our customers depend on us to efficiently manage their supply chains to ensure safety, efficacy, quality, and contain costs.

On Time Delivery

At Excel, we recognize that timeliness is an important factor for customer satisfaction and the assessment of the quality of our products and services. Our customers rely on us to meet their deadlines. We take great pride in our record of meeting (and exceeding) the expectations of our customers when it comes to the timeliness of delivery of the products and services we provide. We closely monitor our delivery record as a quality metric to support customer satisfaction.

Supplier Controls

To ensure the quality of all components and raw materials, we maintain a robust supplier qualification and management system. All prospective suppliers are thoroughly screened and evaluated to establish confidence that they can meet requirements of the goods and services they provide. All suppliers are routinely evaluated for their performance in providing goods and services that conform to specifications in a timely manner. We are diligent in proactively addressing potential supplier quality issues to prevent them from affecting the quality of the finished product. Our customers depend on us to efficiently manage their supply chains to ensure safety, efficacy, quality, and contain costs.


On Time Delivery

At Excel, we recognize that timeliness is an important factor for customer satisfaction and the assessment of the quality of our products and services. Our customers rely on us to meet their deadlines. We take great pride in our record of meeting (and exceeding) the expectations of our customers when it comes to the timeliness of delivery of the products and services we provide. We closely monitor our delivery record as a quality metric to support customer satisfaction.

Validation

Our critical manufacturing processes are validated utilizing statistically sound measures to assure the repeatability of processes yielding conforming product, and to minimize costly scrap. We validate processes including but not limited to injection molding, cleaning, assembly, and sterile packaging. We routinely perform customized data driven process validations (IQ/OQ/PQ) to meet the needs of our customers.

Calibration

To ensure that all products consistently meet defined specifications, we maintain a comprehensive calibration program for the tools and equipment used for manufacturing and testing.

Validation

Our critical manufacturing processes are validated utilizing statistically sound measures to assure the repeatability of processes yielding conforming product, and to minimize costly scrap. We validate processes including but not limited to injection molding, cleaning, assembly, and sterile packaging. We routinely perform customized data driven process validations (IQ/OQ/PQ) to meet the needs of our customers.


Calibration

To ensure that all products consistently meet defined specifications, we maintain a comprehensive calibration program for the tools and equipment used for manufacturing and testing.

Risk Management

Risk Management is culturally instilled at Excel Medical Products. Risk Management Programs are established for all relevant processes and products. Identifying risks, establishing controls, and mitigating the risks to the best extent possible are beneficial not only for internal efficiency and liability exposure, but additionally, and most importantly, the peace of mind our customers expect.

Documentation

All processes at Excel are thoroughly documented to ensure a controlled state of repeatability and reliability. Complete traceability is maintained throughout the product life cycle, from incoming raw resin, to fully traceable sterilization processing records. Many of our customers trust us to maintain and protect their device history records to ensure compliance with all standards and regulations.

Risk Management

Risk Management is culturally instilled at Excel Medical Products. Risk Management Programs are established for all relevant processes and products. Identifying risks, establishing controls, and mitigating the risks to the best extent possible are beneficial not only for internal efficiency and liability exposure, but additionally, and most importantly, the peace of mind our customers expect.


Documentation

All processes at Excel are thoroughly documented to ensure a controlled state of repeatability and reliability. Complete traceability is maintained throughout the product life cycle, from incoming raw resin, to fully traceable sterilization processing records. Many of our customers trust us to maintain and protect their device history records to ensure compliance with all standards and regulations.

FM 515351