Contract Manufacturing Quality

Our Commitment to Quality

Why Lubrizol Life Science Health Values Its Partners’ Success As Much As Its Own Success

As healthcare evolves, patient needs are continuously increasing and advancing. Your customers expect more...and we deliver more. Today's quality standards are tomorrow's baseline standards. Lubrizol Life Science Health (LLS Health) embraces the concept of continuous improvement and maintains robust quality management systems to ensure future success. We utilize sophisticated management techniques, advanced technologies and highly trained personnel in every aspect of our business to ensure that every process produces the highest quality of work. Nothing is more important to our business than delivering precise, repeatable results that are always on time and always within budget. That’s our pledge to you.

Quality Like Your Life Depends On It

LLS Health ensures quality manufacturing solutions for your medical device manufacturing needs through:

  • Compliance with all customer requirements throughout production.
  • Support of good manufacturing practice (GMP) principles.
  • Strict adherence to our ISO 13485:2016 certified Quality Management System.
  • Embracing a culture of continuous improvement.
  • Empowered employees and advanced technologies working together to produce quality medical devices.

Designed for the Latest Regulatory Compliance Requirements

Quality means a lot of things to our partners. In medical device manufacturing, it means strict regulatory compliance. We will work with you to flag and refine any issues that may ultimately affect the product specifications. But most importantly, you can leverage our vast experience and expertise navigating your requirements and mitigate any issues that may keep your device from entering the market. Learn more about how Lubrizol LLS Health can help you navigate the complex regulatory process.

Our Investment in the Best Equipment and Brightest People

  • LLS Health’s Quality Processes: LLS Health develops and validates every process through statistical analysis, so we know it will produce consistent results of the highest quality. Every team member is empowered to stop the production line whenever a concern arises, allowing us to quickly document and troubleshoot potential problems and restore production once we know your product quality standards will be achieved.

  • LLS Health’s Technology: LLS Health utilizes the latest in software and equipment to support our constant drive for unsurpassed quality. Using advanced inspection equipment throughout our manufacturing processes we ensure consistent product quality. And with our enterprise-wide electronic data storage system, we can access data to drive our continuous improvement initiatives

  • LLS Health’s People: From the production line through upper management, our people act on the knowledge that quality is our most important service. Our quality assurance department oversees all efforts for compliance to your manufacturing specifications. And our ongoing training programs constantly evolve, ensuring that our entire team has the knowledge, tools and support necessary to meet your needs.

Our Comprehensive Quality Management Processes

From start to finish, LLS Health cares for the life of your product. Our quality management systems include:

  • ISO Registration: All LLS Health systems are designed to support compliance. LLS Health maintains ISO 13485:2016 certified Quality System and is a certified supplier to many of the top medical device manufacturers in the global healthcare industry.

  • CE Registration: Our PTA balloon catheter platforms (0.035 and 0.014) are CE certified. We are an approved manufacturer for drug-coated balloons in accordance with German pharmaceutical law (AMG).

  • Process Validation: Each step of LLS Health's process is validated. Beginning with pre-production, LLS Health validation includes reviewing design attributes, establishing process parameters, tooling validation, prototyping, testing and inspection. Our quality management system uses industry-standard population statistics, Hi / Lo grouping, pass/fail and capability methods.

  • Lean Six Sigma: In today’s competitive and ever-changing global environment there's no room for error. You can’t afford it. Your customers can’t afford it. That’s why Lubrizol Life Science Health continuously pursues ways to improve quality and increase efficiency, supporting your Six Sigma processes. It’s important to you, so it’s important to us. LLS Health incorporates Lean Six Sigma quality management principles at every level of our operation to verify that quality standards are being met, and to identify areas in need of improvement. We have Six Sigma black belts driving Six Sigma guidelines throughout the organization, and we’re committed to helping more qualified individuals obtain black belt certification. 

  • Analytics and Reporting: LLS Health conduct gauge reproducibility and repeatability studies, and our running validation includes a first article inspection report, qualification data collection and statistical analysis. We continually analyze the results and use them as guides for refinement of our process. 

Upholding the Latest Industry Certifications and Standards

Your products must meet the most stringent standards imaginable. You need a manufacturing partner that can meet those demands. LLS Health is fully qualified to manufacture medical device components that comply with the applicable domestic or global standards. Our Six Sigma trained resources apply our quality management system to your product development process and ensure compliance with your Six Sigma requirements.