Quality That Drives Progress
Trusted Solutions, Proven Integrity
At Solesis, quality is more than a standard; it’s a promise to our customers and the patients who depend on them.
Uncompromising Integrity
Projects are guided by ISO 13485:2016 certified Quality Management Systems to deliver innovative, high-quality solutions from concept through commercialization, supporting Class I, II, and III medical devices.
Driven by a culture of continuous improvement and open communication, we uphold the rigorous standards our partners expect at every stage. Our meticulous document and process controls underpin our focus on quality in development, manufacturing, quality control, and delivery of every product and medical device component we produce.
With seven manufacturing sites in the United States and Costa Rica, we safeguard product integrity and quality in ISO 14644 Class 7 and 8 cleanrooms—ensuring excellence is built into every step of our process.
Unmatched Expertise in Quality
Excellence at Every Step
Our teams are passionate about quality and regulatory compliance, fostering a culture of accountability and innovation to overcome challenges and consistently exceed expectations. By following current Good Manufacturing Practices (cGMP) and maintaining a robust QMS through internal audits, proactive measures, and ongoing management review, we deliver the quality and trust our partners rely on.
Our Solesis family of companies serve as an extension of your team to ensure the off-the-shelf product we deliver or the custom solution we develop together performs to the highest standards.
Throughout the product lifecycle, our team ensures quality in every component by leading:
Inspection Planning
Develop inspection methods/plans and test-method validation to identify component specifications, visual standards, and critical features
Deviation & CAPA Management
Drive investigations, define root causes, and develop action plans for Corrective and Preventive Actions (CAPA)
Validation & Qualification Management
Support the development, approval, and execution of process-validation protocols, and perform component capability assessments for qualification reports of critical processes and qualification activities
Continuous Improvement
Utilize statistical techniques and Six Sigma tools to analyze processes and drive ongoing improvement activities
Risk Management
Proactive identification and mitigation of risks, including leading Process Failure Mode and Effects Analysis (pFMEA) development and implementation, process control plans, and quality agreements
Training & Education
Ongoing training programs ensure our teams are empowered with the knowledge to maintain and enhance quality standards
Change-Control Management
Implement structured change controls to ensure compliance
Ready to Experience the Solesis Difference?
With a relentless commitment to quality and expertise across the product lifecycle, Solesis is dedicated to empowering your success by delivering innovative, consistent, and scalable solutions.