Medical Devices – ISO 13485

OMNEX a global management system training organization, is now offering QMS Lead Auditor training based on both ISO 13485:2016 and international Medical Device Single Audit Program (MDSAP). The five-day training is focused on international MDSAP and ISO 13485 compliant medical device auditing methods. “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 conduct audits of ISO13485: 2016 management system requirements in accordance with the new MDSAP Audit Model. OMNEX’s Lead Auditor Training course will teach students to plan, conduct, report and follow-up on QMS audits in accordance with ISO 13485:2016 and MDSAP. Auditing standards include MDSAP requirements, ISO 19011 & ISO 17021 (MDSAP auditors need to follow ISO 17021)

Considering the ISO 13485:2016 management system requirements and various regulatory authorities compliance requirements around the world and the global supply chains involved, for multinational organizations, a comprehensive program like ‘OMNEX’s MDSAP Lead Auditor Training’ is incredibly valuable. The course provides extensive practical training and hand-on exercises, which will help prepare medical device auditors to identify critical nonconformities and meet international regulatory requirements.” The course is designed for medical device professionals with responsibility for conducting or implementing internal audits, supplier audits or corporate audits. Quality directors, regulatory managers and professionals responsible for managing internal, corporate, supply chain or certification responsibilities may also benefit from the program.

Upon completion the participants will be capable to audit ISO 13485:2016 and all-participating applicable regulatory body compliance requirements. OMNEX also offers the ISO13485/MDSAP Lead Auditor Training course available at client locations around the world.

Participants in the training will learn from highly experienced instructors with decades of experience in medical device quality management systems. Upon completion of this training, delegates will be able to support their organization to maintain compliance to ISO 13485 and jurisdiction requirements in the countries participating in the MDSAP program.

This course will help you:

• Improve auditing skills focused on regulatory auditing
• Assess your own audit models and suggest improvement
• Be prepared to support an efficient MDSAP audit by your selected Auditing Organization

Participants will gain the Knowledge and skills to:

• Demonstrate awareness of MDSAP fundamentals
• Explain the structure and scope of the MDSAP audit
• Maintain MDSAP and organizational regulatory compliance
• Understand MDSAP reporting and nonconformity grading methods
• Explain the differences between MDSAP and other QMS audits such as ISO 13485:2016
• Determine MDSAP documentation requirements
• Prepare to host a successful MDSAP audit
• Audit seven MDSAP auditing process requirements
• Plan, conduct and lead MDSAP audits
• Analyze data sources and control interactions required during process audits
• Use correct jurisdictional terminology
• Understanding auditing to ISO 19011 and ISO 17021 requirements

Who should attend?

Quality Assurance and Regulatory Affairs professionals within medical device organizations currently active in participating jurisdictions and organizations expanding their market reach to jurisdictions participating in MDSAP.

Recommended Training and/or Experience

Thorough understanding of ISO 13485:2016 with experience in auditing ISO 13485:2016 QMS.

Course Duration: 5 days

How will I learn?

Our high impact accelerated learning approach that increases learning by improving knowledge retention and skill application. This course is activity-based, resulting in a deeper understanding of the material and a greater impact on job performance.