BIOTRONIK Inc

Industry:	Medical Devices & Equipment
Revenues:	$52.7 Million
Employees:	1,425

Description

For over 40 years, BIOTRONIK has stood for excellent workmanship and superior safety. Our quality concept follows an integral approach and extends from preventative risk measures during a product's development phase through all the steps of the value-added chain.

BIOTRONIK's quality assurance measures guarantee that both legal standards and guidelines as well as our internal quality standards are upheld. Regular inspections as well as testing of our products and manufacturing processes contribute significantly to this achievement.

Our customers, patients, and physicians can rely on the highest degree of safety. We always welcome suggestions from users about how we can improve the quality of our products.

Our quality system is based on four principles:


Our entire product development process is accompanied by strict inspections that ensure the highest degree of quality. Using modern risk management methods, we identify possible errors in individual components and in the production process. Risk management helps us optimize inspection and testing processes.

We continuously inspect our products as well as important manufacturing steps.

We regularly and critically inspect the quality standards of our products and our manufacturing steps.

We continually optimize all quality-related processes.

Regular auditing by external parties ensures impartial monitoring of our quality system. In this way, we fulfill the requirements of:


ISO 9001, EN 46001, ISO 13485 quality standards


the MDD and AIMD European guidelines


and U.S. quality system regulations (FDA).

Products & Services

medical device, biomedical technology, pacemakers

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News Archive

New TRUST Trial Data Confirm Clinical Benefits of BIOTRONIK Home Monitoring[R]. Biotech Week; 9/16/2009 BIOTRONIK SE & Co. KG, the pioneer of wireless...Congress 2009 demonstrate the benefits of BIOTRONIK Home Monitoring in the early detection...office follow-up visits (see also BIOTRONIK SE & Co. KG). BIOTRONIK... ...more

BIOTRONIK Launches Evia Pacemaker Series. Business Wire; 10/27/2009 ...amp; remote follow-up BERLIN -- BIOTRONIK SE & Co. KG, the pioneer of wireless...portfolio. New Bradycardia portfolio BIOTRONIK continues its product innovation stream...remotely monitored through the proven BIOTRONIK Home Monitoring([R]) wireless system... ...more

BIOTRONIK Home Monitoring[R] Receives Industry's First Approval to Safely Replace Hospital Visits for Cardiac Device Follow-Ups. Business Wire; 10/15/2009 BERLIN -- BIOTRONIK SE & Co. KG, the pioneer of...remote patient monitoring technology. BIOTRONIK Home Monitoring([R]) is now approved...FDA approval granted in May, 2009. BIOTRONIK Home Monitoring([R]) is the first... ...more