Medical Devices are at least as important as Pharmaceutical and Biotechnology products. In order to prevent the negative effects of medical devices on the end user and minimize the risks, the steps of design, development, production and marketing of the device should be carefully examined and the processes controlled. Medical Device audits should be conducted by taking ISO standards and GMP criteria into account. It is desirable for medical device auditors to have superior audit experience with extensive product and process knowledge.
By recognizing what integrated supply chain means for our customers and always prioritizing it as the most important initiative, we use use the guidelines from several International regulatory authorities.