Medical device manufacturers are monitored by notified bodies and by national and international authorities. In regular audits or inspections, your processes are checked against normative and regulatory requirements.
Do not run the risk of getting critical deviations, or even a lawsuit or a warning letter. With the help of a structured-state analysis, our employees discover existing gaps and deviations in your quality management system and take appropriate measures to prepare you for the audit in the best possible way.
Based on our many years of experience in dealing with inspection and audit situations, our experts can prepare your employees for the upcoming event and provide you with help and advice during and after the inspection. Benefit from our experience during the preparation, monitoring and evaluation of third-party audits.
In addition to planned audits, there will be more unannounced audits by notified bodies in Europe. Regulation (EU) 2017/745 as well as Regulation (EU) 2017/746 require a notified body to randomly perform unannounced audits at least once every five years at the manufacturer’s sites and, where applicable, at the manufacturer’s supplier and/or supplier subcontractor sites. In these unannounced on-site audits, the notified body will examine an appropriate sample of the manufactured products or a reasonable sample of the manufacturing process to determine whether the product complies with the technical documentation. The notified body, after completion of the on-the-spot audit, will provide the respondent with a report containing the result of the sampling test.
As a manufacturer of medical devices, you must be prepared for every day to be an audit day. You must always keep your documentation up to date. We can assist you in implementing regulatory requirements and prepare you for every audit situation.