Quality Assurance

Committed to Patients, Committed to Quality:

Our commitment to quality is embedded in our culture. We strive for consistently delivered products manufactured to the highest quality standards in the medical device industry. Harmac’s commitment to quality goes beyond manufacturing; it is part of everything we do. From new product development to responsive customer care and business processes, the Harmac team works to continually improve the effectiveness of our quality management system as a foundation for business performance.

How We Help:

  • Certified for Excellence

    • Harmac utilizes a company-wide and 21 CFR Part 11 compliant digital quality management system. It ensures that all products are always manufactured using reliable, repeatable and compliant processes.
    • Harmac's quality management system routinely garners accolades from Auditors worldwide as one of the best in the industry.
    • The Harmac quality management system is designed for Current Good Manufacturing Practice compliance in order to provide world-class production of Class I, II and III devices including those with Premarket approval (PMA).
    • ISO 14644-1 Class 8 certified cleanrooms including the capability to achieve Class 7 certification.
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