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Quality saves lives. Manufacturers and suppliers in medical engineering are exposed to high liability claims, as there are lives depending on the functionality of their products. Quality Management Systems (QMS) have proven successful in realizing the requirements like those stipulated by the American Food and Drug Administration (FDA). Since 1999 Babtec caters to the needs of medical engineering businesses, supplying computer-aided quality assurance and advance planning of quality-related processes.
QMS software by Babtec is suited for quality-related tasks in biomedical engineering, pharmaceuticals, implant manufacturing, the assembly of therapeutic and diagnostic equipment (e.g. for dialysis, laboratories or medical imaging technology), the production of packaging and dressing materials as well as other industries of the medical sector.
For your planning, quality assurance and management processes, the QMS solution BabtecQ supports a standards-compliant conversion from paper to electronic records. The compliance with applying rules and regulations is constantly monitored and documented, thus offering traceability at any given time.
Audit Management
Efficiently use the experience gained during an audit.
CAPA Management
Prevent repeated errors through targeted actions.
FMEA: Failure Mode and Effects Analysis
Identify and avoid potential errors during the development process.
Complaints Management
Reduce complaints – for satisfied customers and optimized processes.
Incoming Goods Inspection / Outgoing Goods Inspection
Check incoming and outgoing goods - avoid additional costs and time.
Other companies operating in the medical technology and pharmaceutical industries are also already relying on Babtec. You can read the success stories of selected customers in our case studies.
It is internationally recognised: the high quality of medical technology instruments from Germany. Find out how DANNORITZER Medizintechnik GmbH & Co. KG – DANmed for short – from Tuttlingen in Baden-Württemberg contributes to this, you can read in the case study. As one of the leading medical technology manufacturers, the company relies on Babtec software for its quality management.