Quality System

Our Commitment to Quality


TissX has developed the Quality Policy to be appropriate for its mission which is to provide value in all aspects of our business activities. It is TissX’s Quality Policy to:

  • Understand and meet customer requirements for product performance and service;
  • Comply with medical device regulatory requirements including:

COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices, consolidated through amendment M5, Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007;

  • ISO 13485: 2016; Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes;
  • 21 CFR 820: Medical Devices; Current Good Manufacturing Practice (CGMP); Final Rule; Quality System Regulation (QSR);

Quality Certification



The TissX, Inc. Quality System has undergone a conformity assessment by Notified Body BSI, and as a result was issued a BSI Certificate stating that TissX, Inc. holds Certificate No. FM 641224 and operates a Quality Management System which complies with the requirements of ISO 13485:2016.

Quality System

TissX operates under our certified Quality System following ISO 13485 and ISO 22442.

TissX has successfully passed external audits of our Quality System and Manufacturing Facility.

Quality Certification

Certificate of Suitability 

NO. R0-CEP 2018-135-REV 00


Questions? Please contact us.

If you have any questions about our certifications or quality system, please do not hesitate to contact us. We are more than happy to answer any of your questions! 

6455 City W Pkwy Suite 100, Eden Prairie, MN 55344

  • regulatory@tissx.com
  • 763-205-9787