Medical Device

Medical device auditing requires technical knowledge as well as a deep understanding of international medical device regulations. Students participating in this course will gain knowledge and skills to implement a QMS with ISO13485:2016 management system requirements.

This seminar fully covers the ISO 13485:2016

requirements. Auditing topics from ISO 19011 such as the auditing process and methodologies, e. g. planning and conducting an audit, writing nonconformity statements, preparing an audit summary and report, and verifying corrective actions are also covered with a focus on ISO 45001:2018.

This 3-day course has been developed to satisfy the Exemplar Global MD, AU Examination Profiles and, as such, all attendees who successfully pass the exams during this course will achieve a Certificate of Attainment for the following competency units: Exemplar Global MD, Exemplar Global AU

Long-term success of an organization relies on continually assessing to optimize their processes and to account for the unexpected in managing risk.

Taking EU MDR from Complex to Simple.

Understanding MDSAP training course will teach students to plan, develop and implement a QMS in accordance with MDSAP and ISO 13485:2016 requirements.

Learn to plan, develop and implement a quality management system with MDSAP. The four-day training is focused on international MDSAP and ISO 13485 compliant medical review requirements and auditing methods.  

Gain the technical knowledge needed to understand international medical device regulations. This course is designed for medical device professionals with the responsibility for conducting or implementing internal audits, supplier audits, or cooperate audits.