Standard Operating Procedure (SOP) for Design & Development as per ISO13485:2016

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish guidelines and procedures
for the design and development of medical devices in compliance with the requirements of the
ISO13485:2016 standard. This SOP ensures that all design and development activities are carried out
systematically, consistently, and in accordance with regulatory requirements.

2. Scope

This SOP applies to all personnel involved in the design and development process of medical devices
within the organization. It covers all stages of the design and development process, from initial
concept to final product release.

3. Definitions

- Design: The process of determining the product requirements and developing the specifications for
a medical device.

- Development: The process of transforming a design concept into a final product, including activities
such as prototyping, testing, and validation.

- ISO13485:2016: An international standard for the quality management system of medical device
manufacturers.

4. Responsibilities

4.1 Design and Development Team

- The design and development team is responsible for developing and implementing the design and
development process in accordance with this SOP and ISO13485:2016 requirements.

- The team must ensure that all design and development activities are documented, controlled, and
reviewed throughout the process.

- They are responsible for identifying and addressing any potential risks or issues that may arise
during the design and development process.

4.2 Quality Assurance

- The quality assurance team is responsible for overseeing the design and development process to
ensure compliance with ISO13485:2016 requirements.

- They must conduct regular audits and inspections to verify that the design and development
activities are being carried out as per the defined procedures.

- They are responsible for identifying and implementing corrective actions in case of non-compliance
or deviations from the established procedures.

5. Design and Development Process

5.1 Design Planning

- The design and development team must develop a detailed plan outlining the design and
development activities, including timelines, resources, and deliverables.
- The plan should identify all applicable regulatory requirements and standards that need to be
considered during the design and development process.

5.2 Design Inputs

- The design and development team must identify and document the design inputs, including user
needs, intended use, and performance requirements.

- The team should consider factors such as safety, effectiveness, and usability when defining the
design inputs.

5.3 Design Outputs

- The design and development team must document the design outputs, which include the detailed
specifications, drawings, and other relevant documents necessary to produce the medical device.

- The design outputs should be reviewed and approved by the appropriate stakeholders before
proceeding to the next stage.

5.4 Design Verification

- The design and development team must conduct verification activities to ensure that the design
outputs meet the defined design inputs.

- Verification activities may include testing, analysis, and inspection of the product to confirm that it
meets the specified requirements.

5.5 Design Validation

- Design validation is the process of ensuring that the final product, when used under normal
conditions, will consistently perform its intended purpose.

- The design and development team must conduct validation activities to demonstrate that the
product meets the user needs and intended use requirements.

5.6 Design Transfer

- The design and development team must ensure a smooth transition of the design to the production
phase.

- This includes transferring all relevant design documentation, specifications, and requirements to
the production team.

6. Documentation

- All design and development activities must be documented in accordance with the organization's
document control procedures.

- Design and development records, including design inputs, outputs, verification, and validation
activities, must be maintained and accessible for review by internal and external auditors.

7. Training and Competence

- All personnel involved in the design and development process must receive appropriate training
and demonstrate competence in their respective roles.
- Training records should be maintained to ensure that all personnel meet the necessary
qualifications and competency requirements.

8. Change Control

- Any changes to the design and development process must be controlled through a formal change
control procedure.

- Changes should be evaluated for their impact on product quality, safety, and regulatory compliance
before implementation.

9. Risk Management

- The design and development team must conduct risk management activities in accordance with
ISO14971:2019 to identify and mitigate potential risks associated with the medical device.

- Risk management activities should be documented and reviewed throughout the design and
development process.

10. Compliance and Audit

- Regular internal audits and inspections should be conducted to verify compliance with this SOP and
ISO13485:2016 requirements.

- Any non-compliance or deviations from the established procedures should be documented and
addressed through appropriate corrective and preventive actions.

11. Records Retention

- All design and development records, including design inputs, outputs, verification, and validation
activities, should be retained in accordance with the organization's record retention policy.

12. References

- ISO13485:2016 - Medical devices -- Quality management systems -- Requirements for regulatory

purposes

- ISO14971:2019 - Medical devices -- Application of risk management to medical devices

ISO13485:2016 is an internationally recognized standard for the design and development process of
medical devices. This standard sets forth requirements for organizations involved in the design,
development, production, installation, and servicing of medical devices. It provides a framework for
ensuring that these organizations consistently meet customer and regulatory requirements.

The design and development process according to ISO13485:2016 consists of several key stages.
Let's take a closer look at each of these stages:

1. Design and Development Planning:

This initial stage involves defining the objectives of the design and development process, establishing
the necessary resources, and identifying the responsibilities and authorities of the personnel
involved. It is essential to create a comprehensive plan that outlines the activities, deliverables, and
timelines for each phase of the process.

2. Design Inputs:

In this stage, the organization identifies and documents the requirements and specifications for the
medical device. This includes gathering information from various sources such as customer needs,
regulatory requirements, and market research. The design inputs should be clear, complete, and
unambiguous to ensure that the resulting product meets the intended purpose.

3. Design Outputs:

Once the design inputs have been established, the organization proceeds to develop the design
outputs. These outputs typically include detailed drawings, specifications, and other relevant
documents that describe the characteristics of the medical device. It is crucial to ensure that the
design outputs are accurate, complete, and suitable for the subsequent stages of the process.

4. Design Review:

At this stage, a formal review of the design is conducted to evaluate its adequacy and compliance
with the design inputs. This review involves relevant stakeholders, including designers, engineers,
and quality assurance personnel. The purpose is to identify any design-related issues or concerns
that need to be addressed before proceeding further.

5. Design Verification:

Design verification involves confirming that the design outputs meet the specified design inputs. This
is typically done through testing, analysis, or other objective methods. The organization must
establish and implement appropriate procedures to ensure that the verification activities are
conducted effectively and the results are documented.

6. Design Validation:

Design validation is the process of confirming that the medical device, when used under specified
conditions, meets the intended purpose and user requirements. This is typically done by conducting
clinical evaluations, performance testing, and other relevant activities. The validation results should
be documented and compared against the predetermined acceptance criteria.

7. Design Transfer:

Once the design has been verified and validated, it can be transferred to the production phase.
Design transfer involves ensuring that all necessary documentation, specifications, and knowledge
are effectively communicated to the production team. This includes providing training and support
to ensure a smooth transition from design to manufacturing.

8. Design Changes:

Throughout the lifecycle of a medical device, there may be occasions where design changes are
necessary. ISO13485:2016 requires organizations to establish procedures for managing these
changes. This includes evaluating the impact of the change, documenting the rationale, and ensuring
appropriate verification and validation of the modified design.

9. Design History File:

Throughout the design and development process, it is essential to maintain a Design History File
(DHF). The DHF is a compilation of all records and documents associated with the design and
development of the medical device. It provides a complete and traceable history of the design
activities and serves as a reference for regulatory audits and inspections.

In conclusion, adhering to the design and development process outlined in ISO13485:2016 is crucial
for organizations involved in the medical device industry. By following these stages, organizations
can ensure that their products meet customer expectations, comply with regulatory requirements,
and ultimately contribute to the safety and effectiveness of medical devices.