InstructorRoyed Training
TypeOnline Course
Price$250 USD / 13750 INR.
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mdsap training

Introduction

Who should attend

Features

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mdsap training program by royed

The Medical Device Single Audit Program (MDSAP) is a globally recognized auditing program specifically designed for medical device manufacturers. This comprehensive training course is designed to equip participants with the knowledge and skills necessary to understand the MDSAP requirements, prepare for audits, and implement effective quality management systems compliant with MDSAP standards.

MDSAP training helps to understand the MDSAP requirements, prepare for audits, and implement effective QMS compliant with MDSAP standards.

In addition, this MDSAP training course challenges students and Professionals to apply what they have learned through the use of interactive exercises, reflection questions, and a final assessment at the end of the course.

The course can be completed at any place. So, it allows the user to stop and start at their leisure. 

Moreover, user can access the course at own pace. Hence, it allows the user to stop and start at their leisure. 

Snapshot of the course

  • Course Code: RYD-117
  • Course Title: Competency Development Training on The Medical Device Single Audit Program (MDSAP)
  • Access Duration: 1 Week course. However, user can complete the course anytime within 7 days anytime. It means, if anyone want to complete within 3 or 4 days, it is possible.
  • Nature of the course : Online distance learning course. Course can be accessed online across anywhere 24×7.
  • Certification: Certificate will be provided at the end of the successful completion of the course.

Who should attend?

  • This course is designed for professionals working in medical device manufacturing companies, including quality assurance managers, regulatory affairs specialists, compliance officers, and anyone involved in implementing or maintaining quality management systems compliant with MDSAP standards.

Objective of the MDSAP Training

  • Understand the purpose and scope of the MDSAP.
  • Familiarize participants with the MDSAP audit process and requirements.
  • Learn how to develop and implement a quality management system compliant with MDSAP standards.
  • Gain insights into regulatory requirements and expectations across participating MDSAP jurisdictions.
  • Acquire practical knowledge on preparing for and undergoing MDSAP audits.
  • Learn best practices for maintaining MDSAP compliance and continuous improvement.

Important Learning Features of MDSAP Training: 

  • Online 24×7 access from anywhere. Hence, one can learn at your convenience.
  • Hence, the course provides timing flexibility. In other words, one can attend the lecture sessions at your own convenient time.
  • Interactive E-lectures helps user to understand of the concepts effectively.
  • Above all, course provides simulation for real life working. Hence, it helps user to apply the decision making skill in real life scenarios.

MDSAP Course Coverage Area

Introduction to MDSAP

  • Overview of the MDSAP program
  • Objectives and benefits
  • Participating regulatory authorities

MDSAP Requirements

  • Key components of the MDSAP
  • MDSAP audit model
  • Requirements of MDSAP participating countries (USA, Canada, Brazil, Australia, Japan)

Quality Management System (QMS) Essentials

  • Understanding ISO 13485:2016 and its alignment with MDSAP requirements
  • Documentation and record-keeping requirements
  • Risk management and CAPA (Corrective and Preventive Actions)

Preparing for MDSAP Audit

  • Audit planning and preparation
  • Conducting internal audits
  • Corrective actions and follow-up

MDSAP Audit Process

  • Audit scheduling and logistics
  • Audit conduct and interactions with auditors
  • Post-audit activities and responses to audit findings

Maintaining MDSAP Compliance

  • Continual improvement strategies
  • Monitoring regulatory updates and changes
  • Addressing non-conformities and implementing corrective actions

This comprehensive online MDSAP training course aims to provide participants with the necessary knowledge and skills to navigate the complexities of the MDSAP program. Hence this training ensures the compliance with regulatory requirements and fostering a culture of quality and continuous improvement within their organizations.

Section 1MDSAP Training
Lecture 1Introduction to MDSAP | Objective | Significance | Role and responsibilities of stakeholders | Key benefits | MDSAP Process structure and Audit Tasks
Lecture 2QMS and MDSAP | Differences and Similarities | MDSAP Vs. ISO 13485 : Key objectives and differences 
Lecture 3MDSAP Stakeholders 
Lecture 4MDSAP Process Structure Audit Task
Lecture 5MDSAP Document Preparation
Section 2Labeling Requirements for Medical Devices
Lecture 6Medical Device Labeling Guideline | General Principles | Wherever applicable (specific) Labeling contents 
Lecture 7Instruction for Use (IFU)
Lecture 8UDI | Different Component | How to design  
Section 3EU REGULATION FOR MEDICAL DEVICES
Lecture 9EU MDR Classification
Lecture 10EU MDD | EU MDR | Articles | Rules | Pages | Annex | Key Changes in EU MDR
Lecture 11EU MDR  | Annexes | Key notes
Lecture 12EU Medical Device Regulation System | MDR | IVDR | UDI | EUDAMED | Requirements for manufacturer | Importer | Distributor | Declaration of Conformity (DoC)
Lecture 13EU MDR Guideline | EU MDR - Annexes 
Lecture 14EU MDR Conformity Assessment procedure | Assessment of various classes and types of the devices | Key points to consider | Conformity assessment master chart 
Lecture 15EU MDR Authorized Representatives | Mandate | Role and Responsibilities
Lecture 16EU MDR Compliance Process 
Lecture 17Thumb Rules of Classification as per EU MDR Guideline | Invasive | Non-invasive | Active | Special Devices 
Lecture 18Review: DDF DHF DMR MDF DHR
Section 4QMS, Documentation and Dossier Preparation
Lecture 19Medical Device Technical File
Lecture 20Medical Device Dossier Preparation | Section Wise Dossier Preparation | Key Requirements regarding dossier | Points to note regarding each section of the dossier 
Lecture 21Quality Management System (QMS) for medical devices company 
Lecture 22Quality Risk Management | ICH Q9 | ISO 14971 | Principle of Risk Management 
Lecture 23Comparing Medical Device Regulations | 510k Submission | Technical File | Design History File | Design Master File 
Lecture 24Medical Device Essential Principle Checklist | Documentation |  Open file
Lecture 25Implant Card | Regulatory Importance | Content | How to design 
Section 5CE MARKING
Lecture 26Introduction to CE Marking
Lecture 27CE- Self Certification
Lecture 28General principles of the CE marking
Lecture 29Manufacturer Responsibilities
Lecture 30Third Party Medical Device Manufacturing & CE Marking
Lecture 31Classifying Medical Devices Based on the Type of Manufacturing Operation
Lecture 32Understanding Terminologies - OBL/PBL/PLM/OEM/OES
Lecture 33Step By Step CE Marking Process
Lecture 34Case Study
Section 6ISO 13485:2016 : IMPLEMENTATION IN MEDICAL DEVICE ORGANIZATION
Lecture 35Introduction to ISO 13485:2016
Lecture 36ISO 13485:2016 Audit Checklist
Section 7MDSAP documents and Guidelines
Lecture 37DMRs
Lecture 38DHRs
Lecture 39DHFs
Lecture 40Validation Records
Lecture 41Compliant File
Lecture 42MDSAP Checklist
Lecture 43MDSAP Guideline documents (Downloads)