Certifications
Our standards – tested, confirmed, transparent.
Quality is no coincidence - it is the result
MED TRUST offers first-class products with comprehensive quality management.
In medical technology, quality is not only expected – it is essential. When it comes to products that come into direct or indirect contact with people’s health, the highest safety and quality standards are a must.
EN ISO 13485:2016 is a globally recognised standard for the development of a quality management system (QMS) for medical device manufacturers. The recurring annual certification by the Notified Body forms the background of trustworthy medical devices.
The aim is to ensure defined product quality standards by means of consistent processes in order to meet the constantly growing requirements of customers and authorities.
Up to date
The authorisation of a medical device requires expert personnel, know-how, adequate financial resources and time.
As the medical device industry continues to evolve, it is becoming increasingly important to know and understand the details of regulatory standards and management systems in order to ensure the safety, quality and functionality of medical devices.
The MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation) specify the requirements to be fulfilled in order to be allowed to place a medical device on the European Union market. The manufacturer is responsible for the respective product and places it on the market with all rights and obligations.
Responsibility and care
A clear signal to our customers: We work with the utmost responsibility and care.
The quality we deliver meets globally recognised norms and standards and creates the framework for compliance and quality assurance.
This is because compliance also includes acting in accordance with voluntary commitments, internal company specifications and obligations voluntarily entered into by third parties. In other words, everything that gives the product its value over and above the statutory, contractual and regulatory minimum requirements.
