EXCO scrutinizes your quality management systems and registration documents
So that audits do not produce any surprises
National and international industrial companies in regulated markets are now closely monitored by the relevant authorities. Placing products on the market requires that these are approved by the nominated bodies and fulfil the legal requirements. Auditing ensures that the requirements in your company are fulfilled cross-departmentally.
Analysis and result evaluation
EXCO employees carry out an analysis and evaluate the results. As a result, you will receive independent feedback about the efficacy and structure of your quality management system. We will identify process gaps and sources of errors and support you in fulfilling the regulations.
Fulfil regulations. Pass audits.
Auditing in the medical technology industry
Meeting regulatory requirements
Audits and inspections in regulated industries are required by the legislator in keeping with the requirements of the GMP and DIN-EN-IEC regulations. For both manufacturers and their external suppliers and service providers, audits ensure that the quality-relevant products and services are performed in compliance with the rules.
We know the specific GxP regulations for each industry in Europe (93/42/EEC) and America (FDA) for both the product and connecting systems and processes. We convey the requirements of the EU guidelines for good manufacturing practice and examine and compare the manufacturing practice of our customers with the regulatory guidelines.
We will prepare you for audits by external bodies. Because we are not an accredited body, we can introduce corrective measures based on the results of our audits in order to rectify any deviations from guidelines and optimize individual processes or complete quality assurance systems.
We will check your supplier processes and quality in accordance with your guidelines and evaluate the performance of your suppliers. As specialists in supplier development, we will ensure that the quality you demand is understood by your suppliers and provided.