ITK Engineering AG – now EN ISO 13485:2003 certified
20.08.2009
Our medical technology development has successfully received EN ISO 13485:2003/AC:2007 certification, qualifying for software development for medical devices.
ISO 13485:2003 describes the requirements related to regulations and processes for the quality management system of medical devices manufacturers."Our corporate philosophy is based on high quality standards for our services. This is the only way to achieve our goal of maximum customer satisfaction. Compared to ISO 9001, the guidelines in the medical technology are far stricter due to the safety-sensitive relevance involved in these products. We are proud that we have been able to implement these increased requirements within a short period of time and at the first go into a working quality management system”, says Michael Englert, founder and CEO of ITK Engineering AG.
Even Lutz Schüle, the company’s QM representative and development engineer in the fields of medical technology is very pleased: "The certification proves that we align our work consistently with quality and efficiency. We document that our development processes and methods comply with the high level of the medical technology."
For the development ITK applies the most advanced development and testing tools including Rhapsody, Polyspace or Cantata++. Especially through static and dynamic code analysis including code coverage, the quality in the fields of verification and validation is sustainably improved. By using Polarion’s Application Lifecycle Management System (ALM), we implement the software life cycle efficiently, extensively and, above all, traceably – the ideal prerequisites for your product approval.
