Medical Devices : ISO 13485 Internal Auditor

5/5
12
iso 13485

Duration :

2

hour(s)

Skill level:

Regulatory

Language:

English

Final exam:

Yes

Certificate of Completion:

Yes

CEU / CPD Accreditation:

Yes

Certification:

Successful completion provides learners with a dated, traceable and downloadable certificate for the course : 

Each certificate is CPD/CEU accredited and 21 CFR PART 11 compliant. Certificates validity can be checked online through our certificate online checker. They can also be shared on Linkedin.

Description:

Enhance your expertise in quality management with our “ISO 13485:2016 Internal Auditor” course. This program is meticulously crafted for professionals in the medical device industry—specifically Quality Assurance Managers, Regulatory Affairs Specialists, and Quality Systems Engineers—who are looking to strengthen their auditing acumen.

📚 Course Highlights:

  • In-depth understanding of both ISO 13485:2016 and ISO 19011:2018 standards.
  • Interactive exercises in audit planning, execution, and reporting.
  • Strategies for impactful corrective actions and consistent audit follow-up.

 

Guided by industry experts, this online training course provides a practical and comprehensive dive into the audit cycle of medical devices, equipping you with the skills needed for exceptional internal audit performance.

🚀 Certification:

Complete the course to receive a traceable, uniquely numbered certificate of completion, providing evidence of your updated qualifications. The certificate, bearing the date of issue, can be downloaded as a PDF and is print-ready for inclusion in your professional records.

Step into a leadership role in quality assurance within the medical device field. Begin your journey today and establish yourself as a pivotal part of your organization’s commitment to excellence in internal auditing.

 

Curriculum:

 

Introduction

 

Overview of ISO 13485 : 2016 Standard Internal

 

Lesson 1: Quality Management System

 

Lesson 2: Management Responsibility

 

Lesson 3: Resource Management

 

Lesson 4: Product Realization

 

Lesson 5: Measurement, Analysis, and Improvement

 

Glossary

 

Evaluation

Author:

ciaran
Dr. Ciaran McEnister
Senior Pharmaceutical Executive with 25+ years of experience in Medical Device Development, Translational Research, Pharmaceutical development, Pharmacologic/Toxicologic and Preclinical research and Regulatory compliance of small and large molecule drug candidates. Dr. McEnister has an extended experience as senior quality manager.

Reviews:

5/5
12
USD: United States (US) dollar ($) ^

$60

Buy now
This course includes:
One-year access
Updated content every month
Certificate of completion

GxP-Training Benefits

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$60.00 / year

$60.00 / year

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