SUMMERY OF DESIGN VERIFICATION AND VALIDATION OF

532NM RETINAL LASER DEVICE

532NM Retinal Laser Device manufactured by Omesis Medikal design verificatiopn and validation
includes the following steps:

1. DESIGN AND DEVELOPMENT REQUIREMENTS

2. CREATING THE DESIGN AND DEVELOPMENT PLAN
2.1.1. Establishment of the design and development team
2.1.2. Determination of design and development team roles and responsibilities
2.1.3. Literature search for design and development
2.1.4. Design and development requirements analysis
2.1.5. Establishing quality objectives for design and development
2.1.6. Performing risk analysis for design and development
3. DETERMINING DESIGN AND DEVELOPMENT INPUT
3.1. Determination of function, performance and safety requirements based on user needs for
design and development
3.2. Identification of applicable legislation and regulations
3.3. Application of similar design process knowledge
3.4. Other requirements for design and development
3.5. Implementation of risk management outputs
4. DETERMINING DESIGN AND DEVELOPMENT OUTCOMES
4.1. Meeting input expectations for design and development
4.2. Determination and preparation of purchasing, production and service needs for design
and development
4.3. Determination of product acceptance criteria for design and development
4.4. Identification of specific features of the device in routine use for design and development
5. DESIGN AND DEVELOPMENT REVIEW
5.1. Reviewing whether the design and development covers desired features and needs
5.2. Identifying problems, if any, and planning necessary actions for design and development
6. VERIFICATION / VALIDATION OF DESIGN AND DEVELOPMENT
6.1 Verification by validations and tests that the design inputs determined for design and
development are in conformity with the design outputs obtained and that the conformity with the
design is in line with the determined standards
7. CONTROL OF DESIGN AND DEVELOPMENT CHANGES

All the necessities, plans, input determination and output determination steps for design and
development were defined, studied and verified at the same time by the morphological and
histological examination taken as a result of the clinical study. Observing and reporting that the
532nm Retinal Laser device, the prototype of which was developed by Omesis, in the tissues
examined as a result of morphological and histological studies, created similar tissue burns with
the Dorc brand Laserstar endolazer device, which was studied as the standard control group, was
successfully achieved with the necessity, plan, determination of the inputs for design and
development, and obtaining the expected outputs. has been concluded.

The process after the desired outputs obtained from the design and development procedure is the
manufacturing process of the device case, which is planned with our company-specific design, in
which the LED light source can also be integrated and the Application of Risk Management Output
for the Device Case, and the finalization of the 532nm retinal laser device.

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 SUMMERY OF DESIGN VERIFICATION AND VALIDATION OF
532NM RETINAL LASER DEVICE

In addition, the Technical File of the device was created according to the design outputs. The
Technical File is the file that contains the definition of the device, purpose of use, classification, all
technical drawings, all suppliers, production procedure and all test steps, basic requirements, risk
analysis work and clinical studies according to the design and development work of the device.
After the design and development outputs, the user manual of the device is the other output of the
design and development. The risks foreseen as a result of the design and development work, the
measures taken and the applications are also among the design and development outputs.

DESIGN AND DEVELOPMENT REVIEW

Review of Design and Development Covering Desired Features and Needs

Within the scope of the design and development procedure, all steps of design and development
were defined, monitored, implemented and recorded. The entire procedure was implemented
according to the design and development plan, and design and development inputs were
determined in line with user needs and applicable legislation and standards to be followed.
Attached is the minutes of the meeting held as the design and development team to review all the
phases studied and applied until the review phase in the Design Procedure created according to
EN 13485.

Identifying Problems and Planning Necessary Actions for Design and Development

It is planned as the implementation and follow-up of the decisions taken at the attached YGG
meeting.

VERIFICATION / VALIDATION OF DESIGN AND DEVELOPMENT

Verification by validations and tests that the design inputs determined for design and
development are in conformity with the design outputs obtained and that the conformity with the
design is in line with the determined standards
The main validation of the design and development was the clinical study and its results, which
were also mentioned in the sections above. As a result of the prototype device covering all the
expected outputs from the design technically, the results of the use in the operating room
environment, which was made after the case design with ergonomics and usability and bearing
the outputs, was presented to Assoc. Dr. The final product, which Bahri Aydın describes as
completely user-friendly, has been reached. Application of all the measures taken against the
created risk analysis and 60601 tests, which are the validation of the standards that the device
must meet, 60825, 60601-1-8, Usability Engineering studies and production, test, validation and
control forms including all work steps followed in each device production and all steps were
recorded and traceability was established.
In addition, the result that the desired design and the obtained outputs were successful with the
Technical File Chapter 10 After-sales follow-up has been confirmed by user comments.

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