Design and Development Plan

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Design and Development Plan


This Medical Devices Development Plan describes in detail all essential steps to be considered prior to start the development of medical devices and is in alignment with current FDA and EMA expectations.



This Design and Development Plan describes the overall development program. The Design Review Committee approves the Development Plan which decribes in detail the complete medical devices development project.


Regulatory basis, reference documents

  • 21 CFR Part 820 - Quality System Regulation, Subpart C - Design Controls, 820.30 Design controls
  • ISO 13485:2016: Medical Devices - Quality management systems Requirements for regulatory purposes
  • FDA/CDRH - Design Control Guidance for Medical Device Manufacturers, March 11, 1997
  • 21 CFR Part 820-Quality system Regulation, Subpart G- Production and Process Controls
  • ISO 14971 Medical Devices: Application of Risk Management to Medical Devices


Table of Content

1          Purpose and Objective

2          Regulatory basis, reference documents

3          Responsibility and accountability

3.1       Company Management

3.2       Design Review Committee

3.3       Quality Assurance

3.4       Project Leader (PL) / Head of Engineering (HE)

3.5       Function / Area Leaders

4          Related documents

5          Definitions

6          Procedure

        Content of a Design and Development Plan

6.1       General

6.1.1    Scope 

6.1.2    Applicable to

6.1.3    Goals and Objectives

6.1.4    Intellectual Property Position   

6.1.5    Clinical Trials Approach

6.1.6    Facilities and Capital Equipment Required

6.1.7    QA Approach

6.2       Product Description

6.2.1    Description of Product

6.2.2    System Block Diagram

6.2.3    Target Market

6.2.4    Regulatory Approach

6.2.5    Regulatory Approach

6.2.6    Third Party Certification Approach

6.2.7    Packaging and Labeling

6.3       Division of Responsibility and Interfaces

6.4       Project Team

6.4.1   Team members and responsibilities

6.4.2    DRC members

6.5       Activity Schedule, including Deliverables and Key Milestones       

6.6       Deliverables for each Phase

6.6.1    Design Input Phase

6.6.2    Design Output

6.6.3    Design Verification

6.6.4    Design Validation

6.6.5    Design Transfer

6.7       Manufacturing

6.7.1    Projected Manufacturing Volume with timeline

6.7.2    Service

6.8       Project Administration

6.8.1    Meeting Frequency

6.8.2    DHF Control

6.8.3    Design Reviews

6          Attachments

7          Plan distribution

8          Health, safety and environmental considerations



Size and Format:

Microsoft Office

2003 Word File

12 pages Plan

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