V & V Medical Device

Medical Device Verification and Validation

Seaskymedical is a manufacturer of medical products and injection molds. As a professional manufacturer of medical devices, Seaskymedical has the ability to verify and validate the process of the medical products manufacturing. In addition, we design and manufacture material, tools, instruments and other equipment for medical purposes.

Professional Medical Device Verification and Validation

The verification and validation of medical devices is a complex process. There are many aspects to the entire process, but Seaskymedical can follow the best methods of manufacturing to help manufacturers to verify and validate medical devices.


Moreover, Seaskymedical has a team of professionals who can guarantee the “professional medical device verification and validation.” We can also provide a variety of services that can make the medical devices verification and validation reliable and more effective.

Professional Medical Device Verification and Validation in Seaskymedical

Newly deployed processes, established processes that require periodic qualification, and existing processes that have been updated, extended (volume or scope), experienced a decline in performance, or have seen an increase in customer complaints should all be validated. The following are common instances of procedures that should be validated, per GHTF recommendations: (now the IMDRF).


In contrast, manual cutting procedures, visual examination of printed circuit boards, and testing of wiring harnesses are processes where product verification is adequate. In such instances, the output of a process can be examined with high precision and dependability. Even with these processes, the causes of variance must be identified and controlled.

When is the Best Time to Consider V&V in Product Development?

  • V&V encompasses all phases of product development as well as a vast array of technologies. Electronics, mechanical/physical engineering, fluids, thermal systems, evaluation of electromechanical component, instrumentation, biological concerns, etc. are all examples.

    When developing product requirement specifications, it is crucial to consider V&V early in the design verification testing medical device phase. For instance, adding test points to circuit boards, having accessible connectors, having data storage/retrieval capabilities, and making things modular can enhance a product’s testing capability and save time and money. Using existing proven materials or coatings for a product can decrease V&V expenses. Clarity, conciseness, measurability, acceptable tolerances, precision, and testability might influence the final design and overall manufacturability. Future V&V testing medical device actions will be evaluated based on these criteria.

Design Validation & Verification for Medical Device

Seaskymedical can design a variety of medical devices, such as medical computer integrated equipment or a variety of medical supplies. We can also provide a variety of services to help manufacturers verify and validate the design of a medical device or ensure the product specification.

Validation for Medical Device Manufacturing

In Seaskymedical validation in medical device is a process that is critical for the development of each medical device. Seaskymedical is a professional manufacturer of medical devices that can provide a range of services to ensure the validation of the medical devices.

Medical Device Packaging Validation

Packaging validation requirements for medical devices in Seasky medical is a process to verify the packaging of medical devices. We are a professional manufacturer of medical devices, and we can also provide experience in packaging validation to ensure the packaging of the medical device.

How Do We Apply V&V Testing in the Medical
Device Molding?

In terms of medical device molding in Seaskymedical, the injection molding testing is a crucial step before the production of medical device. There are many different tests to be applied, such as wall thickness, cavity strength and small batch testing. But the most important point is the impact on the overall quality of medical device.

FDA Software Validation

In the FDA software validation process, the company will find out the software used in the medical plastic injection modling device. It would be useful to find out the software used in medical device before the medical device is made. Validation and verification medical device will greatly help to ensure the accuracy and quality work of a medical molding company.

Thermal Analysis of an Assembly

In Seaskymedical, the thermal analysis of an assembly is a method of testing the device or the parts. Different thermal analysis tools will be used in the testing of the device, such as infrared thermal analyzers, infrared radiometers, or differential scanning calorimetry.

Fault Tree Analysis of a Process or Design

The fault tree analysis of a process or design will be tested in Seaskymedical to ensure the process or design’s accuracy. The results of the fault tree analysis will be used to assess the process’s effectiveness.

Failure Modes and Effects Analysis

We will perform the failure modes and effects analysis as a method of evaluating the effect of the device on the human body. The failure modes and effects will be analyzed so that the device can be adjusted to meet the needs of the user.

Package Integrity Tests

Seaskymedical’s package integrity tests are based on the device’s internal and external factors. After the device is manufactured, the package integrity tests will be adjusted to ensure the package’s integrity.

Biocompatibility Testing of Materials

Biocompatibility testing of materials is a method used by Seaskymedical to ensure the safety of the materials on humans. Biocompatibility tests, for example, can be performed on any type of material that will be used in the medical device. The medical device’s materials will also be tested.

Bioburden Testing of Products to Be Sterilized

The bioburden testing of products in sterilization validation for medical devices at Seaskymedical is a test to evaluate the safety of the materials or devices. Materials testing can be done on products such as medical equipment, medical devices, or medical supplies.

Why V&V Medical Device is So Important in the Process of Medical Molding?

To produce a high-quality medical device validation, the medical device manufacturing process must be carefully developed by qualified and experienced personnel. We, the manufacturer, will be in charge of the medical device verification and validation.


The most important point is that the medical device manufacturing process must be carried out in accordance with the manufacturer’s quality management system (QMS). QMS is a systematic approach to ensuring the quality of medical device production.

When the company’s engineers, designers, and technicians collaborate and participate in the verification and validation medical device process, they will be able to thoroughly understand the validation requirements as well as the QMS requirements. These are the following reasons on why is it so important:

Guarantees Safety

The manufacturing process for medical devices will be thoroughly scrutinized. When it comes to medical device verification and validation, the most difficult and important job is ensuring the safety of the medical device. Verification and validation in medical divice with high accuracy will ensure the quality, safety, and effectiveness of medical device manufacturing.

Ensures Effectiveness

The use of the best methods and tools can ensure the effectiveness and reliability of design verification medical device. Seaskymedical has a team of professionals who can introduce the best methods, tools, and techniques to aid in the validation and verification of medical devices.

Guarantees Sterile Requirement for Medical Device

Through effective verification and validation, the sterile packaging validation of the medical device injection molding will be ensured. All medical device verification and validation equipment must be sanitary and clean room contract manufacturing. The verification and validation of medical devices should take place in a clean and sanitary environment.

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