Quality

watermark

Over 35 years of experience
developing a thorough understanding of the complex regulatory environment.

Quality Culture

Lives depend on our products

Lives depend on our products — that’s why we are committed to achieving the highest possible standards of quality in everything we do. Every policy and every process in our operations across the globe is designed and continuously monitored for full FDA and international compliance.

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Quality Policy

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Seisa’s Commitment

Seisa is committed to providing products that meet our customers’ expectations by maintaining our QMS and complying with regulatory requirements.

Regulatory Compliance

Over 35 years of experience

With over 35 years of experience in compliance with FDA and international regulations and audits, Seisa has developed a thorough understanding of the complex regulatory environment. From concept through validation and commercial release, our team designs and builds with regulatory compliance in focus. We have been delivering Class III and PMA devices for over 15 years and our global facilities are all ISO-13485 certified.

  • ISO 13485:2016 Certified
  • Class I, II, and III devices, including Premarket Approval (PMA)
  • FDA registered and compliant with Code of Federal Regulations part 820
  • ISO 7 and 8 – certified cleanroom controlled environments
  • In-house metrology labs
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