Quality is not just an end result, it is our attitude.
Strict controls that ensure the highest degree of quality are conducted throughout the entire product development process. After a new product has been developed, it undergoes a great deal of rigorous internal testing. Using modern risk management tools, we identify possible errors in the design and in the production process. Such tools enable us to optimize inspection and testing processes. Only when we are absolutely confident that the product and the methods to produce it will be extremely safe and reliable, is it submitted for commercial approval.
During manufacturing, every single component, every process is tested and compliance with specifications are tested and monitored again and again. For one CRM lead alone, there are over 80 production steps backed by over 300 quality checks. And we do not just check the products – we check how we check the products – continuously learning, adapting and improving. At BIOTRONIK, we do not just comply with industry quality manufacturing standards, we create new ones.
After manufacturing and before shipping, every device then undergoes full function tests. These tests can exceed the industry standard up to ten times in quality and quantity, in order to give us complete confidence that our promise of exceptional quality is guaranteed.
Quality is not just an end result, it is your experience.
Year after year our Product Performance Reports prove that your experience with BIOTRONIK products are that they are highly reliable – backing up our promise that they are carefully developed, accurately manufactured, thoroughly tested to ensure unquestionable quality.
Quality is not just a claim, it is audited and authorized.
Our products are approved by the Food and Drug Administration (FDA) and by the European Union. Additionally, the TÜV and other independent authorities regularly audit our production and development sites in order to ensure the conformity with objective quality standards and impartial monitoring of our quality system. In this way, we fulfill the requirements of the following norms:
Product Performance Report