MDSAP Auditor Skills Training that provides learners with the knowledge and skills required to understand and complete an audit against the IMDRF Medical Device Single Audit Program (MDSAP) for medical device quality management based on ISO 13485 and international regulatory bodies medical device regulations.
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MDSAP Auditor Skills Training
Our Blended Learning Methodology is a hybrid of highly interactive eLearning theory modules that are completed first before attending skills-based Live Instructor Workshops that focus on practical application in a real life context.
Face to Face Learning
On completion of this course, successful Learners will have the knowledge needed to:
- Explain the purpose of a medical device single audit program (MDSAP) medical device quality management system audit process in the context of ISO 13485 and regulatory compliance.
- Explain the role and responsibilities of an auditor to plan, conduct, and report nonconformities for a quality management system audit in accordance with ISO 17021, regulatory body requirements and the MDSAP audit criteria.
- Plan for and conduct an audit of a medical device quality management system, report, and grade non-conformities to establish compliance with ISO 13485 and regulatory requirements using MDSAP methodology.
A summary of learning topics within this course include:
- Purpose and Benefits of an MDSAP Audit
- Who Recognizes MDSAP Audits
- Role of the IMDRF and its members, plus links between IMDRF and the GHTF
- MDSAP’s Relationship to ISO 13485 and international regulatory requirement documents
- MDSAP Competence and Training Requirements for Auditing Organizations
- MDSAP potential application scope in relation to medical devices
- MDSAP Audit Cycle
- Planning Considerations for MDSAP Audits
- 7 Chapters of MDSAP Audit Process
- Non-Conformance Reporting as required by GHTF SG3 including escalation rules
- Determining Audit Objectives
- Audit Team Competencies & Selection
- Conducting on-site audit activities including logistical planning, audit meetings, gather and verifying objective evidence and determining audit findings
- Auditing using the MDSAP Approach
- Generating Audit Findings
- Reporting Audit Findings including grading requirements
- Quality Assurance Professionals
- Quality Engineers
- Regulatory Professionals
- Internal Auditors
- Lead Auditors
Exemplar Global certify this course under the Recognized Training Provider scheme. Successful completion of this course will entitle the Learner to a digital Certificate of Achievement.
Prior to attending this course, learners must be informed that they are expected to have the following prior knowledge:
- Must have successfully completed a CQI and IRCA Certified MD-QMS ISO 13485 Lead Auditor course or equivalent.
Medical device management systems
Knowledge of the following quality management principles and concepts:
- The relationship between ISO 13485 and applicable international regulatory requirements for medical devices.
- Commonly used quality management terms and definitions within ISO 13485 and ISO 9000.
- The process approach used in quality management.
- A working knowledge of risk-management principles related to the design of a medical device, through ISO 14971.
To successfully complete this course, each Learner will need to:
- Complete the eLearning modules and obtain 70% or higher in the final assessments (MCQ-based) by the required deadline set in advance of the given workshop dates you are registered for.
- Fully attend the Instructor Workshops as 100% attendance is required.
- Obtain 70% or higher in the graded assessments during the Instructor Workshops
For the live workshops during a virtual delivery, we utilise both Zoom and Microsoft Teams.
Learners need to individually have:
- PC or MAC Computer
- Reliable Internet
- Video Webcam
- Headset or Earbuds
- Quiet Setting
In relation to the eLearning Modules, in our experience, Workplace IT environments’ internal configurations and available software can vary (new or old), and there may be various limitations or other restrictions in place, and as such, the functionality of any Learning Management System (LMS) may be impacted, restricted and may not perform well. Read the full technology requirements here.
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