Mimetis Biomaterials Company Policy
Mimetis Biomaterials is committed to maintaining the effectiveness of its Quality Management System and to providing high quality and safe medical devices through robust
and effective process controls, rigorous quality criteria, and the fulfilment of customer and regulatory requirements.
Mimetis is committed to guaranteeing quality in all of its activities. The management ensures the effectiveness by living and practicing the following statements:
● Assurance of product quality;
● Establishing and measuring quality objectives and performance of processes;
● Enforcing risk management for each process;
● Committing to achieve total customer satisfaction through the prevention of defects and excellent customer care;
● Ensuring that all employees are fully competent and aware of customer and regulatory requirements;
● Ensuring that this quality policy has been communicated and comprehended by all employees;
● Providing a safe environment for the company’s employees;
Mimetis Biomaterials’ Quality Management system has been carefully constructed to ensure that our products are designed and manufactured to consistently meet and satisfy the specific needs of our customers and requirements according to:
● ISO 13485:2016
● EC Directive 93/42/EEC and its modification 2007/47/EEC.
● Spanish Law RD 1591/2009.
● Regulatory requirements of all our customer countries and their updates.
● Regulation EU 2017/745 of the European Parliament and of the council of 5 April 2017 on medical devices
The proper function of the internal Quality Management system is continuously reviewed by
management through internal audits and periodic management reviews.