Quality Assurance

Medical Device Textile Solutions

The journey to product commercialization requires medical devices that consistently perform to meet market needs and patient requirements. Quality of raw materials, testing, and manufacturing processes is vital to the success of those medical devices.

Partner with Secant Group’s team to take your device design plans into full-scale custom medical device component production. As a quality-award-winning ISO 13485:2016-certified, notified body-audited manufacturing facility with a footprint that exceeds 150,000 sq. ft., Secant works with manufacturers to maintain the highest possible quality and product integrity throughout the production process within ISO 14644 Class 7 and 8 cleanrooms.

Unmatched Expertise in Quality

Secant serves as an extension of your team to ensure medical device textile components perform to the highest standards. Throughout the product lifecycle, Secant Group ensures quality in every textile component by leading:

  1. Inspection Planning: Develop inspection methods/plans and test method validation to identify component specifications, visual standards, and critical features
  2. Validation and 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
  3. Risk Management: Lead risk management activities, including Process Failure Mode Effects Analysis (pFMEA) development and implementation, process control plans, and quality agreements
  4. Change Control Management: Implement change controls to ensure compliance
  5. Deviation and CAPA Management: Drive investigations, define root causes, and develop action plans for Corrective and Preventive Actions (CAPA)
  6. Continuous Improvement: Utilize statistical techniques and Six Sigma tools, analyze processes, and drive continuous improvement activities

Start your medical device project today.

Contact us to learn more or explore resources on medical device textiles.