Written By:
Other references
Version:
Date: DESIGN AND DEVELOPMENT PLAN Document Number:
(Your company logo)
Comment [PM1]: Document all information, Author, Revision, cross related references etc
PREPARED BY: PRINT NAME
POSITION
SIGNATURE
DATE
REVIEWED BY: PRINT NAME
POSITION
SIGNATURE
DATE
APPROVED BY: PRINT NAME
POSITION
SIGNATURE
DATE
Document Title: Design Development Plan Template
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Comment [PM2]: Appropriate sign offs
Written By:
Other references
Version:
Date: DESIGN AND DEVELOPMENT PLAN Document Number:
(Your company logo)
1 PROJECT DESCRIPTION The XXXX is a new product development project for a medical device with the capability to deliver a prescribed XXXX. Small batch builds will be generated post-design realisation and verification phase to assess the product in preliminary clinical trials. A feasibility report of product performance will be generated and as an input into the next iteration of the XXXX project. XXXX has overall project control and will follow XXX – Design Control to ensure compliance with ISO 13485:2016.
Comment [PM3]: As an example, what is the project about, Comment [PM4]: What is in scope and what is out of scope?
1.1 Scope: Describe the project briefly. This XXXX is applicable to the XXXX project. The XXXX defines the project team, support resources, deliverables and other necessary planning for the XXXX project. It describes the systematic approach for control of the design and development activities of this project. It provides or contains references to the needed items to be in compliance with XX Design and Development Planning.
Comment [PM5]: Any definitions used in this document?
1.2 Definitions / Acronyms Terms/Acronym s
Definitions
URS
User Requirement Specification
PRS
Product Requirement Specification
FMEA
Failure Mode Effective Analysis
RMF
Risk Management File
DHF
Design History File
DMR
Device Master Record
1.3 Applicable Documents and References Document # XXX PXXX XXX XXX
Document Title User Requirement Specification Product Requirement Specification Design Control Design Development Plan
Date
Revision # XX XX XX XX
XX XX XX XX Comment [PM7]: what is the product? detail all necessary information
2 PRODUCT DESCRIPTION The XXXX a medical device with the capability to deliver a prescribed XXXX. Document Title: Design Development Plan Template
Comment [PM6]: Internal and External references, keep this appropriate
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