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MDSAP Requirements for Practitioners and Auditors Course & Certification
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About
MDSAP Requirements for Practitioners and Auditors provides a practical overview of the Medical Device Single Audit Program (MDSAP) requirements for medical device quality management systems and regulatory compliance. It helps learners understand the MDSAP framework, participating regulatory authorities, process-based auditing, risk management, audit planning, sampling and selection, and the linkage between interconnected audit processes.
This course covers the key MDSAP audit processes, including management, measurement, analysis and improvement, device marketing authorisation and facility registration, adverse events and advisory notices, design and development, production and service controls, and purchasing. It also explains the evaluation of objective evidence, audit trail development, nonconformity grading, and the importance of documenting audit findings consistently. Upon successful completion, learners will gain practical knowledge to support audit preparation and execution, strengthen quality management system compliance, and address applicable regulatory requirements across participating jurisdictions.
Who Should Enrol?
- Medical Device Auditors
- Quality Assurance and Quality Management Professionals
- Regulatory Affairs Professionals
- Regulatory Compliance Professionals
- Medical Device Manufacturers
- Quality Management System Practitioners
- Professionals involved in MDSAP audit preparation and execution
- Anyone involved in medical device quality management systems and regulatory compliance
What you will learn
Understand the Medical Device Single Audit Program (MDSAP) framework, participating regulatory authorities, and the process-based audit approach, including risk management and the linkage between audit processes.
Learn how to prepare for and conduct MDSAP audits, including audit planning, sampling and selection methods, following audit trails across processes, and evaluating objective evidence against applicable requirements.
Develop practical knowledge of the MDSAP audit processes covering management, measurement, analysis and improvement, device marketing authorisation and facility registration, adverse events and advisory notices, design and development, production and service controls, and purchasing.
Understand how to assess and grade nonconformities, document audit findings, evaluate quality management system effectiveness, and support regulatory compliance across participating jurisdictions.
Course Syllabus
- Three things that are wrong before the audit starts
- Which revision governs, and how to tell
- Why the model is shaped as it is
- The architecture, in one part
- Scope, from the auditor's standpoint
- What this course does not do, and the case that runs through it
- Audit types and the cycle
- Stage 1 and Stage 2, and what Stage 2 actually reaches
- What surveillance guarantees, and what alternates
- Sequence, deviation and sampling
- Audit time
- Nonconformity grading - the centre of the course
- The report, the clocks and the contradictions
- Chapter 1: what the process is for, and why it is first
- Establishing and directing the system, and the grade that follows
- Authority, capability and accountability
- Information, risk, outsourcing, distribution - and two anomalies
- Chapter 2 in its own right, and two impact bands in one clause set
- What auditors look for, and the constructed NCR-2601 worked through
- Chapter 3: what it establishes, and the leads it supplies
- The basis of measurement, analysis and improvement
- Nonconforming product control, feedback and external parties
- Internal audit, the management loop, and the only 8.2.4
- What auditors look for in Chapter 3
- Chapter 4, and each of its two tasks in its own right
- Position in the sequence, and the project the auditor picks
- Scoping, and the planning pair whose clause sets differ
- The design process proper, and the clause that does the work
- Risk management, reached three ways and never as a file
- Software's two answers, and change management's two questions
- Design transfer, the device file, and a finding worked through
- The chapter's shape, and the clause that does not exist
- Planning production, and the conditions it runs under
- Validation, sterilisation, software and measurement integrity
- The records that prove what was built, and traceability
- Acceptance, failure, and everything after the product leaves
- The linkages out, and the jurisdictional overlays
- The grading set-piece, and the constructed NCR-2604 in full
- Purchasing's position, and the correction it opens on
- Block A: scoping the process, and choosing the sample
- Block B: controlling the supplier, and the trap inside it
- Block C: verifying what arrived, and feeding the system
- The supplier-scope extension, and the multi-site question
- The overlays, a record worked in full, and the re-check
- Spine One to Three
- Record One to Six
- Readiness One to Two
- Status Board One to Two
- Five things to re-check, and what closes each of them
- Six Things to Take From This Course
- 📘 Bonus: MDSAP Requirements for Practitioners and Auditors eBook (Free with purchase)
Course Benefits
eBook
Access the course content in eBook format, which can be downloaded and read on your device.
CPD Points
Earn CPD points to support your professional development in Medical Device Single Audit Program (MDSAP) requirements for practitioners and auditors, subject to applicable eligibility criteria.
Certification
Receive a personal certificate upon course completion to demonstrate your knowledge of Medical Device Single Audit Program (MDSAP) requirements for practitioners and auditors.
Affordable
Get excellent value with cost-effective pricing, plus group discounts for larger purchases.
Flexibility
Learn at your own pace with convenient online access, allowing you to complete the course anytime, anywhere.
Keep Up to Date
Stay informed about MDSAP requirements, audit processes, applicable regulatory obligations, relevant guidance, and updates through regularly reviewed course content.
Learn from Industry Experts
Learn from medical device regulatory, quality, and compliance professionals through practical insights into Medical Device Single Audit Program (MDSAP) requirements, audit processes, quality management systems, and applicable regulatory obligations for practitioners and auditors.
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