Quality Management System

We are happy to announce, on 30 March 2021, that we have been recertified by Lloyd’s Register UK to the ISO 13485:2016 Quality standard for the design, development, manufacture and supply of polymer scaffolds.

The ISO 13485:2016 medical device quality system approval allows us to design, develop, manufacture and supply scaffolds suitable for use in implantable medical devices.

Based on ISO 9001’s process approach to quality management, ISO 13485 focuses on what we, as a manufacturer, do to deliver safe and effective medical devices. We have been certified since 2015 and updated our QMS from 13485:2003 to 13485:2016 in 2018. The standard was updated to keep up with changes in the medical device industry and to address changes in the underlying ISO 9001 standard. This places greater emphasis on risk management and risk-based decision making processes and is more closely aligned to the US FDA 21 CFR Part 820 quality system regulations.

Regulatory authorities in most major markets require manufacturers of medical products to have a third-party audited and certified quality management system in place. Our ISO 13485:2016 compliant system ensures that our clients feel total confidence while using our product and services.

Quality Control

  • Our cleanrooms are equipped with desktop Phenom scanning electron microscopes (SEM) loaded with fibermetric software that allows measurement of fibre diameter, fibre diameter distribution and fiber alignment.
  • Scaffold thickness is measured with a manual or digital micrometer and validated with the SEM.
  • We have mechanical testing capability with a bench mounted Tinius Olsen 5ST suitable for tension, compression, shear and other tests to a maximum force of 5kN/ 1000 lbf.
  • Approved suppliers provide GMP grade chemical testing for example for residual analysis
Fibre diameter distribution graph from Fibermetric software
Fibre diameter distribution graph from Fibermetric software
Tinius Olsen 5ST mechanical tester
Tinius Olsen 5ST mechanical tester