Medical Devices QMS

Medical Devices Quality Management System (MDQMS 13485) Personal Certification validates an individual’s knowledge and professional competence in understanding, implementing, and supporting quality management principles applicable to medical devices based on recognized MDQMS requirements. It demonstrates the ability to support regulatory compliance, risk management, product safety, and quality controls throughout the medical device lifecycle, contributing to consistent product quality, patient safety, and continual improvement.

Medical Devices Quality Management System (MDQMS)

Certified organization to conduct Lead Auditor /Auditor & Lead Implementer Trainings for ISO 13485(Medical Devices Quality Management System (MDQMS)). {Certification Body: M/s Staunchly Management and System Services Limited. Accreditation Council is EGAC, a Multilateral Recognition Arrangement (MLA) Signatory, under International Accredited Forum (IAF) (www.iaf.nu)}. MacLead Cert#: IN56337S
Approved Training Partner with Cyber Accreditation Board (www.cyberab.org) an initiative of US Dept of Defense.
Licensed institute partner with CMMI Institute, Pittsburgh, USA (www.cmmiinstitute.com)
Government eMarket Place (GeM) approved Organization (www.gem.gov.in)

Experiential Learning Content (Practice Based)

Introduction to ISO 13485 and Certification Fundamentals

About the course
Learning Objectives
Introduction to ISO 13485
Purpose of ISO 13485
Benefits of ISO 13485
Process of Certification
Benefits of 3rd Party Certification
PDCA Cycle
ISO 13485 Principles
Interpreting the OH&S MS Requirements

ISO 13485 Requirements and Auditing Principles

Review of Day 1 learning
Overview of ISO 13485:2016 Requirements
Guidelines for Auditing
Audit terminology
Principles of Auditing

Audit Roles, Preparation, and Execution

Review of Day 2 learning
Audit Responsibilities
Audit Objectives & Activities
Preparing for a stage 2 audit, including preparing an audit plan
Audit Plan
Preparing Audit Work Documents
Audit Performance
Auditor Confidentiality

Audit Reporting, Meetings, and Mock Audit Practice

Review of Day 3 Learning
Conduction of Audit
Write and grade nonconformity reports
Audit Reporting
Auditor Meeting
Audit conclusions and recommendations clearly to the auditee at a closing meeting
Case Study Mock Audit

Audit Completion, Certification, and Final Assessment

Review of Day 4 Learning
Completion of Audit
Audit follow-up
Certification Scheme for Auditors of Management Systems
Course Summary & Preparation for Examination
Written Examination – 120 Mins

Years of Experience

0 +

Trained Lead Auditors

0 K+

Clientele Count

0 +

New Joiners Weekly

0 +

TESTIMONIALS

Positive Reviews From Our Participants

Excellent training! The blend of theoretical knowledge and hands-on application elevated my auditing skills. Highly recommended for anyone aspiring to become an ISO 27001 Lead Auditor.

Devarakonda Sandeep Student

The program’s focus on real case studies and practical audit planning made a huge difference. I now lead privacy audits with clarity and confidence.

Chintakunta Mounika Student

The training met international expectations for Lead Auditor development and significantly enhanced our professional audit capabilities in information security and privacy management.

Vignesh Sundar Student

The program successfully combined theoretical rigor with practical audit scenarios, enabling participants to develop competence and confidence in leading ISO 27001 audits in complex organizational environments.

Prakash V Student

A well-designed and professionally delivered Lead Auditor course. The content was thorough, relevant, and effective in strengthening our organization’s internal and external audit capabilities.

Srikanta Sahu Student

This program delivered in-depth knowledge of privacy risk assessment, PIMS controls, and audit techniques. The training enhanced our ability to evaluate privacy governance frameworks with confidence and consistency.

Vikram Muralidharan Student

The ISO 27001 implementation process was comprehensive, well-documented, and aligned with best practices. The structured methodology and continuous support ensured timely and successful certification readiness.

Venkat N Student

Our organization benefited significantly from the structured approach to capability improvement. The implementation consultants provided clear guidance, practical tools, and recommendations that aligned with our business objectives.

Chinmay Student

Medical Devices QMS

Medical Devices Quality Management System (MDQMS)

Experiential Learning Content (Practice Based)

Introduction to ISO 13485 and Certification Fundamentals

ISO 13485 Requirements and Auditing Principles

Audit Roles, Preparation, and Execution

Audit Reporting, Meetings, and Mock Audit Practice

Audit Completion, Certification, and Final Assessment

WHAT WOULD IT COST?

MODE OF TRAINING

DURATION

Positive Reviews From Our Participants

Medical Devices QMS

Medical Devices Quality Management System (MDQMS)

Experiential Learning Content (Practice Based)

Introduction to ISO 13485 and Certification Fundamentals

ISO 13485 Requirements and Auditing Principles

Audit Roles, Preparation, and Execution

Audit Reporting, Meetings, and Mock Audit Practice

Audit Completion, Certification, and Final Assessment

WHAT WOULD IT COST?

MODE OF TRAINING

DURATION

Positive Reviews From Our Participants

Register for the Certification

Fix an Appointment (Personal)

Fix an Appointment (Organization)