This Medical Device Design Inputs SOP applies to all medical devices that are approved for Product Development as well as to the personnel who are responsible for implementing Design Controls for such medical devices. This Design Controls SOP does not apply to medical devices in very early stage of development such as early concept or feasibility stages. Design Controls begin after concept and feasibility studies are completed after the COMPANY Management approves the initiation of a Product 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

Table of Content: 

1          Purpose

2          Objective

3          Regulatory basis, reference documents

4          Responsibility and accountability

4.1      Company Management

4.2      Design Review Committee

4.3      Quality Assurance

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

4.5      Function / Area Leaders

5          Related documents

6          Definitions

7          Procedure

7.1      Design Inputs (general)

7.2      Design Input – User Requirements

7.3      Design Input – Product Requirements

7.4      Approving Design Input Documents

7.5      Product Requirements Form (PRS)

7.6      Design History File

8          Attachments (3 pages)  Product Requirements Specification Form

9          SOP distribution

10       Health, safety and environmental considerations

Size and Format of the Medical Device Design Inputs SOP:

• Microsoft Office 2003
• Word File
• 13 pages procedure

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The purpose of this Compliance Checklist CFR 820 is to verify that a organisation is complainant to 21 CFR 820 Quality System Regulations. This evaluation checklist can be used as part of a supplier evaluation or audit process or as an checklist for internal auditing or to perform a gap analysis as part of any compliance program or inspection readiness initiative.

US Food and Drug Administration (FDA) 21 Code of Federal Regulations (CFR) part 820

Table of Content:

1          Purpose & Objective

2          Regulatory basis, reference documents

3          Responsibility and accountability

4          Definitions

5          Procedure

5.1       820.20 – Management Responsibility

5.2       820.22 – Quality Audits

5.3       820.25 – Personnel

5.4       820.30 – Design Controls

5.5       Design and Development planning

5.6       Design Input

5.7       Design Output

5.8       Design Reviews

5.9       Design Verification

5.10      Design Validation

5.11      Design Transfer

5.12      Design History File

5.13      820.40 – Document Controls

5.14      820.50 – Purchasing Controls

5.15      820.60 – Identification

5.16      820.65 – Traceability

5.17      820.70 – Production and Process Controls

5.18      820.72 – Inspection, Measuring, and Test Equipment

5.19      820.75 – Process Validation

5.20      820.80 – Receiving, in-process, and finished device acceptance

5.21      Receiving acceptance activities

5.22      In-Process acceptance activities

5.23      Final Acceptance Activities

5.24      820.86 – Acceptance Status

5.25      820.90 – Non-Conforming Product

5.26      820.100 – Corrective and Preventive Action

5.27      820.120 – Device Labeling

5.28      820.130 – Device Packaging

5.29      820.140 – Handling

5.30      820.150 – Storage

5.31      820.160 – Distribution

5.32      820.170 – Installation

5.33      820.180 – General Requirements

5.34      820.181 – Device Master Record

5.35      820.184 – Device History Record

5.36      820.186 – Quality System Record

5.37      820.198 – Complaint Files

5.38      820.200 – Servicing

5.39      820.250– Statistical Techniques

6          Attachments

Size and Format of the Compliance Checklist CFR 820:

• Microsoft Office 2003
• Word File
• 24 pages checklist – gap analysis

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