DESIGN AND DEVELOPMENT

1. Purpose

This document covers all design requirements to be determined and understood. The company capabilities are sufficient to meet the customer and regulatory requirements. The design process provides communication, information and documentation to ensure safe and performing product design, qualification and transfer to production in compliance with ISO13485.

2. Approval

(Version at end of page)

Signed V14 MR 2022.10.21 -

3. Scope

3.1. This standard operating procedure applies to new products that will be manufactured locally within a cleanroom and/or manufacturing facility and applies to all company product development practices and activities associated with the planning, design, development and transfer of new and modified products. This document does not apply to prior project funding and approval.

4. Responsibilities

4.1. Approval: Author of the document, Marelize Robertson

4.2. Changes: Author of the document, Dean Kowalski

4.3. The COO is responsible to assign a project manager for the project

4.4. The Project Manager is responsible for initiating the design plan, getting the appropriate approvals and holding design reviews

5. Definitions

5.1. Defined user needs: Qualitative requirements derived from market needs.

5.2. Design and development plan: Documentation of goals and objectives of a project including identification of specific tasks, resources, responsibilities and project schedule

5.3. Design: The concept, pilot production, testing and verification, validation, transfer to production and control of new products

5.4. Design verification: Determination that the product meets requirements

5.5. Design validation: Determination of the product's ability to meet user needs

5.6. Design changes: Changes made to the inputs or plan during design and development activities

5.7. Common Specification: A harmonized standard or a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system

5.8. Customer: Recipient of a product provided by the supplier.

5.9. Technical File: Collation of design History and the technical and medical device file documentation requirements. ISO13485 requirements refer SOP Documentation

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

7.1. ISO 13485 : 2016 : Clause 7.3 – Design and Development. This clause refers to design and development management, from initial idea to final acceptance of product. This means that design can’t be used apart from development, and that they represent one single process.

7.2. ISO14971, Medical devices - Application of risk management to medical devices

8. Procedure

8.1. General Principles

8.1.1. Product development should, in principle, follow the waterfall model as seen in the process flow. The company implements design control through the design and development standard operational procedure. The different design controls are implemented in phases as discussed in this SOP.

8.1.2. Design and development is not applicable to ophthalmic eye procedure packs as these products are assembled components or purchased finished goods.

8.1.3. If the organization is performing the design and development process, it must have a documented procedure for design and development. These projects are initiated for new product or process development. The need for a new product or process may arise based on customer requests, market conditions, new product or process ideas and new equipment.

8.1 DESIGN AND DEVELOPMENT PLANNING (7.3.2)

The organisation shall plan and control the design and development of product. These planning documents shall be maintained and updated on the Google drive as the design and development progresses. The following shall be documented:

a). The design and development stages

b). The review(s) needed at each design and development stage

c). The verification, validation and design transfer activities that are appropriate at each design and development stage

d). The responsibilities and authorities for design and development

e). The methods to ensure traceability of design and development outputs to design and development inputs

f). The resources needed, including necessary competence of personnel

Design and development can be performed by one employee who will be responsible for design and development execution. If design and development are performed by a team, the responsibilities must be clearly defined; if other parties are involved in this process, then effective communication must be established. The COO designates a project manager for the project, then the project manager will prepare a design plan

During design and development planning, all its phases must be defined, along with appropriate activities of reviewing, verification, and validation for each phase.

8.2 DESIGN AND DEVELOPMENT INPUTS (7.3.3)

Considering that ISO 13485 refers to design and development of product (not design and development of processes), design and development inputs relate to product requirements that include:

a) Functional, performance, usability and safety requirements, according to the intended use

b) Applicable regulatory requirements and standards for the product,

c) Applicable output(s) of risk management

d) As appropriate, information derived from previous designs

d) Other requirements relevant relevant to design and development of the product and processes such as estimate costs and safety requirements.

These inputs shall be reviewed for adequacy and approved on the design plan document. Requirements shall be complete, unambiguous, able to be verified or validated, and not in conflict with each other.

8.3 DESIGN AND DEVELOPMENT OUTPUTS (7.3.4)

The design and development outputs will be recorded on the design plan document, the output shall:

a) Meet the input requirements for design and development

b) Provide appropriate information for purchasing, production and service provision

c). Contain or reference product acceptance criteria

d). Specify the characteristics of the product that are essential for its safe and proper use

Design and development outputs must be in a form suitable for verification related to input elements and must be approved before acceptance or prior to release. Records of the design and development outputs shall be maintained and they can be in the form of a drawing, engineering documentation, plans, etc.

8.4 DESIGN AND DEVELOPMENT REVIEW (7.3.5)

8.4.1. The purpose of this activity is to determine whether the design and development process goes in the intended direction. The review can be done in appropriate phases or at the end of the project by using the review document available on the Google drive.

8.4.2. The review identifies problems during design and development and suggests actions to resolve them; it can include other interested parties. The design and development review must be documented.

8.4.3. Design review may be conducted as a meeting, a conference call or by circulation on an e-mail. Systematic reviews of design and development shall be performed in accordance with planned and documented arrangements for:

8.4.3.1. Evaluate the ability of the results of design and development to meet requirements

8.4.3.2. Identify and propose necessary actions

8.4.4. Participants in such reviews shall include representatives of functions concerned with the design and development stage being reviewed, as well as other specialist personnel

8.4.5. Records of the results of the reviews and any necessary actions shall be maintained and include the identification of the design under review, the participants involved and the date of review.

8.5 DESIGN AND DEVELOPMENT VERIFICATION (7.3.6)

Design and development verification shall be performed in accordance with planned and documented arrangements to ensure that the design and development outputs have met the design and development input requirements.

The organisation shall document verification plans that include methods, acceptance criteria and as appropriate, statistical techniques with rationale for sample size.

Should the intended use requires the medical device to be connected to or have an interface with other medical devices, verification shall include confirmation that the design outputs meets design inputs when so connected or interfaced

Records of the results and conclusions of the verification and necessary actions shall be maintained. If verification is acceptable the project will proceed to design validation. If the results are not acceptable, the team will determine if a design change is required, if the project will go back to the development stage, or if the project is to be terminated.

8.6 DESIGN AND DEVELOPMENT VALIDATION (7.3.7)

Validation determines whether the product can fulfill requirements for intended use; it is performed before delivery or use of product and must be documented.

The organisation shall document validation plans that include methods, acceptance criteria and, as appropriate, statistical techniques with rationale for sample size. Validation should be conducted on representative product this includes initial production units, batches or their equivalents. The rationale for the choice of product used for validation shall be recorded.

The organisation shall perform clinical evaluations or performance evaluations of the medical device in accordance with applicable regulatory requirements. The product used for these evaluations is not for use to the customer.

Validation shall be completed prior to release of the product for use to the customer. The validation plans such as records, conclusions and the necessary actions shall be maintained must be documented

8.7 DESIGN AND DEVELOPMENT TRANSFER (7.3.8)

The procedure for transfer of design and development outputs to manufacturing must be documented.

The purpose of this procedure is to ensure that the outputs are verified and suitable for manufacturing before final production specifications and that production capability can meet product requirements .

The records of the transfer must be kept.

8.8 CONTROL OF DESIGN AND DEVELOPMENT CHANGES (7.3.9)

8.8.1. Design and development changes shall be documented on the design change form and the organisation shall determine the significance of the change to function, performance, usability, safety and applicable regulatory requirements for the medical device and its intended use.

8.8.2. Changes in design and development can happen in every phase. Before they are implemented they must be reviewed, verified, validated, and approved before application. Records about changes must be kept.

8.8.3. The design change form will be completed and linked to all the design changes opened on Trello under the project task board.

8.9 DESIGN AND DEVELOPMENT FILES (7.3.10)

Considering the importance and complexity of the design and development process, it is reasonable that the standard requires the organization to maintain a design and development file for each medical device type or medical device family. The purpose of this file is to demonstrate conformity to the requirements for design and development, and it must include reference to all relevant documents such as changes and records produced during the design and development process.

9. Process flow chart

10. Revision History

Revision 14; 21.10.2022 - 3. Scope Updated

Revision 13; 31.08.2022 - MR - DK 31.08.2022 - Updated number 3. the scope, Added 7.2 Under references, Added 5.1 and 5.2. under definitions, Added number 9 - Process flow chart, Updated number 8. Procedure added General Principles, 8.8.2 & 8.8.3 Added to Design control changes

Revision 12; 23.08.2022 - MR - DK 23.08.2022 - 8.1. Project plan updated to design plan and linked, 8.8 Design change form inserted and linked, 8.9 Design and development file linked, Added COO and Project manager responsibilities

Revision 11; 27.10.2021 - DK - MR Design and Development Editing - New

Revision 10; 14.10.2021 - MR - Updated responsibilities

Revision 9; 05.08.2021 - MR - Reviewed

Revision 8, 23.06.2021 - TNA - New format with Approval, Scope, Responsibilities and revision history added and new google site format.

Revision 7; Digitally signed on 10.05.2020 by WJW

Revision 1-6, unknown due to google site change to new google site