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

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Description:

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.

Curriculum for this course:

Module 1: Introduction

Overview	45 secs
Course Introduction	1 min 31 secs
CFR, ICH and The FDA	1 min 21 secs
Challenges Facing the Medical Device Industry	1 min 10 secs
Single User License	58 secs
Course Objectives	1 min 09 secs

Module 7: Product Realization – Part A

Planning	1 min 20 secs
Device Planning	1 min 14 secs
Customer Related Processes	1 min 10 secs
Specific Considerations	1 min 45 secs
Disposable Device Example	1 min 25 secs
Review of Requirements Prior to Commitment	1 min 33 secs
Communication	1 min 16 secs
Design and Development – General	1 min 19 secs
Design and Development – General: Common Mistake	1 min 38 secs
Design and Development – General: Document Approval	1 min 42 secs
Design and Development – Planning	1 min 02 secs
Design and Development – Planning (Task Breakdown)	1 min 10 secs
Design and Development – Inputs	1 min 30 secs
Design and Development – Inputs (Three Categories)	1 min 29 secs
Design and Development – Inputs (Adequate Time)	1 min 41 secs
Design and Development – Outputs	1 min 05 secs
Design and Development – Review	1 min 08 secs
Design and Development – Review (Collection of Reviews)	1 min 20 secs
Design and Development – Review (Systematic Process)	1 min 06 secs
Design and Development – Verification	1 min 23 secs
Design and Development – Validation	1 min 10 secs
Design and Development – Validation (MVP)	1 min 31 secs
Design and Development – Transfer	1 min 09 secs
Design and Development – Transfer (DMR)	1 min 46 secs
Control of Design and Development Changes – Document and Change Control	58 secs
Control of Design and Development Changes – Change Request Details	51 secs
Control of Design and Development Changes – Change Levels	1 min 39 secs
Design and Development Files – DHF	1 min 39 secs
Design and Development Files – Product History	1 min 41 secs