ISO 13485:2016

ISO 13485:2016 Product Realization (Chapter 7 – Part A)

The learning objectives for this course are to understand what ISO 13485 is, and what some of the key advantages to an ISO 13485 certification can provide. Also, to provide an in depth understanding of which policies, procedures and systems need to be put in place to be able to implement and maintain compliance with the 13485 standards. In module 7 we will cover Part A of Product Realization including, planning of product realization, customer related processes and design and development.

CEU Credits: 0.1

Course Code: ELM-805

Duration: 60 mins

Skill Level: Intermediate

Language: English

Final Exam: Yes

Certification: Yes

Version: V1.0

Curriculum for this course

Module 1: Introduction

Overview

Course Introduction

CFR, ICH and The FDA

Challenges Facing the Medical Device Industry

Single User License

Course Objectives

Module 7: Product Realization – Part A

Planning

Device Planning

Customer Related Processes

Specific Considerations

Disposable Device Example

Review of Requirements Prior to Commitment

Communication

Design and Development – General

Design and Development – General: Common Mistake

Design and Development – General: Document Approval

Design and Development – Planning

Design and Development – Planning (Task Breakdown)

Design and Development – Inputs

Design and Development – Inputs (Three Categories)

Design and Development – Inputs (Adequate Time)

Design and Development – Outputs

Design and Development – Review

Design and Development – Review (Collection of Reviews)

Design and Development – Review (Systematic Process)

Design and Development – Verification

Design and Development – Validation

Design and Development – Validation (MVP)

Design and Development – Transfer

Design and Development – Transfer (DMR)

Control of Design and Development Changes – Document and Change Control

Control of Design and Development Changes – Change Request Details

Control of Design and Development Changes – Change Levels

Design and Development Files - DHF

Design and Development Files – Product History

Conclusion

Final Assessment

Certification

Author

Don Rackham

Associate Director QA Asterias Biosciences

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