DESIGN & DEVELOPMENT

1. Purpose

To establish a procedure to manage design and development operations

2. Approval

(Version at end of page)

Signed V1 ML 010.05.2021    

3. Scope

This standard operating procedure applies to new products that will be manufactured locally within a cleanroom and/or manufacturing facility

4. Responsibilities

Approval: Author of the document, Monica Lucas

Changes: General Manager

5. Definitions

Protocol - the defined plan for the scope, responsibilities, activities and records for the design and development plan detailing requirements as specified in this SOP.

Qualification - Action of proving that any equipment works correctly and actually leads to the expected results. The word validation is sometimes widened to incorporate the concept of qualification.

Calibration - Activity of verifying the accuracy of a test equipment to SI standards and /or bring the test equipment back to accuracy

Verification - checking compliance to a requirement or specification

Validation - Action of proving, in accordance with the principles of Good Manufacturing Practice, that any procedure, process, equipment, material, activity or system actually leads to the expected results (see also qualification).

Product Family: ISo13485 3.12, medical device family, group of medical devices manufactured by or for the same organization and having the same basic design and performance characteristics related to safety, intended use and function

Medical Device Technical File: ISO13485 4.2.3. For each medical device type or medical device family, the organization shall establish and maintain one or more files either containing or referencing documents generated to demonstrate conformity to the requirement of this International Standard and compliance with applicable regulatory requirements.

The content of the file(s) shall include, but is not limited to:

a) general description of the medical device, intended use/purpose, and labelling, including any instructions for use;

b) specifications for product;

c) specifications or procedures for manufacturing, packaging, storage, handling and distribution;

d) procedures for measuring and monitoring;

e) as appropriate, requirements for installation;

f) as appropriate, procedures for servicing.

6. Abbreviations

D&D – Design and Development

SOP – Standard Operating Procedure

NCCA – Non-conformance Corrective Action

SHEQ – Safety, Health, Environment, Quality

7. References

ISO 13485 : 2016 : Clause 7.3 – Design and Development

Procedure for Non-Conformance Corrective Action

Procedure for Change Control

Procedure for Preventive Action and Risk Assessment

8. Procedure

All new products manufactured within the manufacturing facility shall follow the procedures for: 

Design and Development Planning (Clause 7.3.2); 

Design and Development Inputs (Clause 7.3.3), 

Design and Development Inputs (Clause 7.3.4), 

Design and Development Review (Clause 7.3.5), 

Design and Development Verification (Clause 7.3.6), 

Design and Development Validation (Clause 7.3.7).

A design and development record shall be created as a file for each Product Family manufactured in  the manufacturing facility. Refer 5.9

The record shall include the topics tabled in point 5.1 , as required

The final D&F file Technical documentation is the foundation of the Medical Device Technical File

8.1 Design and Development Planning

Design and Development planning for each manufactured product must include:

1. Identification of all D&D stages and activities.

2. Review points (if applicable), verification, validation and design transfer activities for any of those activities.

3. Defining responsibility for each D&D activity.

4. Defining the resources required for each D&D activity.

5. Defining methods to ensure traceability of D&D outputs to D&D inputs.

The Record of D&D shall include an overview of what should be expected in D&D Planning is shown in the table below:

8.2 Design Reviews

Design reviews should be conducted at relevant stages of the D&D process. Design reviews may be required at different points and are product dependent. 

However, the minimum amount of design reviews required are as follows:

1. After User Needs are drafted

2. After Design Inputs are established

3. After Design Outputs

4. After Design Verification

5. After Design Validation

6. Before Going into Full Production

Design Review Teams

Design review teams should comprise of a minimum of 1 representative from the following departments, which maybe the same person with multiple functions:

1. Management

2. Manufacturing

3. Sales

4. Engineering, which maybe an independent consultant, as required

5. QARA, with or without and independent consultant, as required

8.3 Design Inputs

Design Inputs define the performance criteria, the requirements, and features of the medical device.

1. A Product Requirement Specification should be designed to define design inputs:

a. Requirements: What does the design need to do to be successful. Ie. The minimum requirements.

b. Constraints: Limitations of the design.

c. Criteria: Any additional criteria to improve the product.

2. Functional, performance, usability and safety requirements should be defined.

3. Applicable regulatory requirements and standards

4. Outputs of risk management

5. Information derived from previous similar designs

Key points in creating design inputs include:

1. Design inputs should not be subjective, abstract concepts.

2. Design Inputs should be objective. Measurable.

3. Think of User Needs as a precursor to Design Inputs. (and show how these are linked through a Traceability Matrix)

4. Do not rely on User Needs as the only resource for Design Inputs.

5. Consider industry standards, applicable regulations and competitive products.

8.4 Design Outputs

Design outputs should define, as relevant:

1. Number of Materials

2. Components

3. Sub-assemblies

4. Drawings

5. Technical Specifications

6. Instructions

7. Product Acceptance Criteria

8. Information for purchasing, production and service provision

8.5 Design Verification

Design verification entails proving Design Outputs meet Design Inputs.

Acceptable methods for design validation include: Testing, Inspection and Analysis:

1. Design verification must be planned before tests, inspections and analyses are conducted.

2. Determine the best to prove design outputs meet design inputs.

3. Complete design verification activities and document results.

4. Documented results should include verification methods, acceptance criteria and where required, statistical techniques with rationale for sample size.

8.6 Design Validation

Design Validation entails proving the correct medical device was designed.

1. Validation demonstrates that the medical device meets user needs and its intended uses, which may include sterile barrier system (seal integrity), sterilization validation of the product or product

     process validation e.g. product is consistent to quality and performance from a machine or hand made

2. End users should be involved in design validation.

3. Design validation shall be conducted on a representative product, which will include initial production units, batches or their equivalents. A rationale for the choice of product used shall be recorded.

4. Performance evaluations of the product shall be completed prior to release for use of the product to the customer.

8.7 Design Transfer

Design validation involves the evaluation of products. As a result, the process of transferring a medical device from product development to production begins during design validation.

The procedures shall ensure that the design outputs are verified as suitable for manufacturing before becoming final production specifications and that production capability can meet the requirements.

8.8 Control of Design and Development Changes

Design and development changes shall be controlled and documented. The change will follow Change Control SOP.

Before any changes are implemented, the changes shall be:

1. Reviewed

2. Verified

3. Validated

4. Approved

8.9 Design and Development File

The design and development file shall follow a standard template. Please see attached template.

9. Risk Based Approach

In the event of non compliance follow SOP  NON CONFORMANCE CORRECTIVE ACTION

The Risk Assessment to is found in SOP PREVENTIVE ACTION RISK ASSESSMENT   refer Document

9.1 Trend Analysis and Continual Improvement

An analytical review is reported monthly to management and this forms part of the input through Data Analysis to management review 

The Trend should pick up any potential and recurring incidents, where corrective action must be reported at the management review to facilitate continual improvement.

 10. Revision History

Revision 2;  10.05.2021 - ML -  Digitally signed by ML

Revision 1, 04.05.2021 - new

11. Records 

Name Retained by/ in Retention period Hard copies Destroyed by

Various applicable google DRIVE n/a n/a