Process validation for the medical technology industry<\/h1><\/div>Process validation provides proof of suitability, which demonstrates that the process system used in combination with the product to be processed actually delivers the expected results. As per EN ISO 13485 and ISO 9001, processes must be validated \u2013 provided that the result cannot be verified by subsequent monitoring or measurement. The concept of validation can be interpreted differently. For instance, “validation” is often used as a generic term that covers both the qualification of systems\/equipment and the validation of processes. At KKS, we use the term process validation to refer to the performance qualification of processes.<\/p>\n<\/div>
Every day in the KKS Medical Surface Center, we use validated processes for the surface treatment and final cleaning of medical products.<\/p>\n<\/div>
Safety for your medical products<\/h3><\/div>Take advantage of our experience in process validations!<\/p>\n<\/div><\/div><\/div>
\n- Reproducible and reliable processes thanks to KKS worst-case standard validation of processes and methods<\/li>\n
- Proven experience of KKS as a developer and outsourcing provider of surface treatment processes and as a systems manufacturer<\/li>\n
- State-of-the-art and end-to-end qualified production systems<\/li>\n
- Universal and validated data management and production control system for seamless and tamper-proof traceability<\/li>\n
- Implementation of customer-specific process validations<\/li>\n<\/ul>\n<\/div><\/div><\/div>
![\"Execution](\"https:\/\/kks-surfacetreatment.com\/wp-content\/uploads\/kks_medical-surface-center_process-validation_plant-with-two-employees_960x600px.jpg\" "\\"Execution")
<\/span><\/div><\/div><\/div><\/div><\/div>Outsourcing of surface treatments for the medical technology industry<\/h2><\/div>In the Medical Surface Center, we offer a comprehensive range of services for achieving the perfect surface. Find out more here:<\/p>\n<\/div><\/div><\/div>
<\/i>Medical Surface Center<\/span><\/a><\/div><\/div><\/div><\/i>Outsourcing services<\/span><\/a><\/div><\/div><\/div><\/div><\/div>Outsourcing of surface treatments for the medical technology industry<\/h2><\/div>In the Medical Surface Center, we offer a comprehensive range of services for achieving the perfect surface. Find out more here:<\/p>\n<\/div><\/div><\/div>
<\/i>Medical Surface Center<\/span><\/a><\/div><\/div><\/div><\/i>Outsourcing services<\/span><\/a><\/div><\/div><\/div><\/div><\/div>Process validation for the medical technology industry \u2013 Our experience is your added value<\/h2><\/div>The goal of each process or method validation is to provide proof that the combination of all subprocesses and infrastructure systems consistently delivers a predefined result, as per the defined framework conditions regarding the manufacturing process of a product or product group within the considered limits and acceptance criteria.<\/p>\n<\/div>
KKS worst-case standard validation<\/h4><\/div>We have validated the most commonly used surfaces processes in the Medical Surface Center with defined worst-case reference parts. If your products are covered by a validation of this kind, you may dispense with customer-specific validations when outsourcing surface treatment and final cleaning services. It is up to you to decide if the KKS worst-case product meets your specific requirements. We would be happy to support you in making this decision.<\/p>\n<\/div>
KKS customer-specific process validation<\/h4><\/div>In our Medical Surface Center, we can carry out validations on your behalf that are tailored to your processes and products. Since our process systems are qualified and we have the required expertise in house, validation activities are performed within a relatively short time, extremely efficiently and expertly. The necessary analyses within the context of process validations are carried out in independent, accredited laboratories.<\/p>\n
Validation at KKS Ultraschall AG is performed as per the following V model:<\/p>\n<\/div>
Process validation provides proof of suitability, which demonstrates that the process system used in combination with the product to be processed actually delivers the expected results. As per EN ISO 13485 and ISO 9001, processes must be validated \u2013 provided that the result cannot be verified by subsequent monitoring or measurement. The concept of validation can be interpreted differently. For instance, “validation” is often used as a generic term that covers both the qualification of systems\/equipment and the validation of processes. At KKS, we use the term process validation to refer to the performance qualification of processes.<\/p>\n<\/div>
Every day in the KKS Medical Surface Center, we use validated processes for the surface treatment and final cleaning of medical products.<\/p>\n<\/div>
Safety for your medical products<\/h3><\/div>Take advantage of our experience in process validations!<\/p>\n<\/div><\/div><\/div>
\n- Reproducible and reliable processes thanks to KKS worst-case standard validation of processes and methods<\/li>\n
- Proven experience of KKS as a developer and outsourcing provider of surface treatment processes and as a systems manufacturer<\/li>\n
- State-of-the-art and end-to-end qualified production systems<\/li>\n
- Universal and validated data management and production control system for seamless and tamper-proof traceability<\/li>\n
- Implementation of customer-specific process validations<\/li>\n<\/ul>\n<\/div><\/div><\/div><\/span><\/div><\/div><\/div><\/div><\/div>
Outsourcing of surface treatments for the medical technology industry<\/h2><\/div>In the Medical Surface Center, we offer a comprehensive range of services for achieving the perfect surface. Find out more here:<\/p>\n<\/div><\/div><\/div>
<\/i>Medical Surface Center<\/span><\/a><\/div><\/div><\/div><\/i>Outsourcing services<\/span><\/a><\/div><\/div><\/div><\/div><\/div>Outsourcing of surface treatments for the medical technology industry<\/h2><\/div>In the Medical Surface Center, we offer a comprehensive range of services for achieving the perfect surface. Find out more here:<\/p>\n<\/div><\/div><\/div>
<\/i>Medical Surface Center<\/span><\/a><\/div><\/div><\/div><\/i>Outsourcing services<\/span><\/a><\/div><\/div><\/div><\/div><\/div>Process validation for the medical technology industry \u2013 Our experience is your added value<\/h2><\/div>The goal of each process or method validation is to provide proof that the combination of all subprocesses and infrastructure systems consistently delivers a predefined result, as per the defined framework conditions regarding the manufacturing process of a product or product group within the considered limits and acceptance criteria.<\/p>\n<\/div>
KKS worst-case standard validation<\/h4><\/div>We have validated the most commonly used surfaces processes in the Medical Surface Center with defined worst-case reference parts. If your products are covered by a validation of this kind, you may dispense with customer-specific validations when outsourcing surface treatment and final cleaning services. It is up to you to decide if the KKS worst-case product meets your specific requirements. We would be happy to support you in making this decision.<\/p>\n<\/div>
KKS customer-specific process validation<\/h4><\/div>In our Medical Surface Center, we can carry out validations on your behalf that are tailored to your processes and products. Since our process systems are qualified and we have the required expertise in house, validation activities are performed within a relatively short time, extremely efficiently and expertly. The necessary analyses within the context of process validations are carried out in independent, accredited laboratories.<\/p>\n
Validation at KKS Ultraschall AG is performed as per the following V model:<\/p>\n<\/div>
Take advantage of our experience in process validations!<\/p>\n<\/div><\/div><\/div>
- \n
- Reproducible and reliable processes thanks to KKS worst-case standard validation of processes and methods<\/li>\n
- Proven experience of KKS as a developer and outsourcing provider of surface treatment processes and as a systems manufacturer<\/li>\n
- State-of-the-art and end-to-end qualified production systems<\/li>\n
- Universal and validated data management and production control system for seamless and tamper-proof traceability<\/li>\n
- Implementation of customer-specific process validations<\/li>\n<\/ul>\n<\/div><\/div><\/div><\/span><\/div><\/div><\/div><\/div><\/div>
Outsourcing of surface treatments for the medical technology industry<\/h2><\/div>
In the Medical Surface Center, we offer a comprehensive range of services for achieving the perfect surface. Find out more here:<\/p>\n<\/div><\/div><\/div>
<\/i>Medical Surface Center<\/span><\/a><\/div><\/div><\/div><\/i>Outsourcing services<\/span><\/a><\/div><\/div><\/div><\/div><\/div>Outsourcing of surface treatments for the medical technology industry<\/h2><\/div>
In the Medical Surface Center, we offer a comprehensive range of services for achieving the perfect surface. Find out more here:<\/p>\n<\/div><\/div><\/div>
<\/i>Medical Surface Center<\/span><\/a><\/div><\/div><\/div><\/i>Outsourcing services<\/span><\/a><\/div><\/div><\/div><\/div><\/div>Process validation for the medical technology industry \u2013 Our experience is your added value<\/h2><\/div>
The goal of each process or method validation is to provide proof that the combination of all subprocesses and infrastructure systems consistently delivers a predefined result, as per the defined framework conditions regarding the manufacturing process of a product or product group within the considered limits and acceptance criteria.<\/p>\n<\/div>
KKS worst-case standard validation<\/h4><\/div>
We have validated the most commonly used surfaces processes in the Medical Surface Center with defined worst-case reference parts. If your products are covered by a validation of this kind, you may dispense with customer-specific validations when outsourcing surface treatment and final cleaning services. It is up to you to decide if the KKS worst-case product meets your specific requirements. We would be happy to support you in making this decision.<\/p>\n<\/div>
KKS customer-specific process validation<\/h4><\/div>
In our Medical Surface Center, we can carry out validations on your behalf that are tailored to your processes and products. Since our process systems are qualified and we have the required expertise in house, validation activities are performed within a relatively short time, extremely efficiently and expertly. The necessary analyses within the context of process validations are carried out in independent, accredited laboratories.<\/p>\n
Validation at KKS Ultraschall AG is performed as per the following V model:<\/p>\n<\/div>
![\"Chart:](\"https:\/\/kks-surfacetreatment.com\/wp-content\/uploads\/kks-schaubilder_07-v-modell_prozessvalidierung_1080px_EN.svg\")
<\/a><\/span><\/div>![\"Picture](\"https:\/\/kks-surfacetreatment.com\/wp-content\/uploads\/kks_business-units_engineering_960x600px.jpg\" "\\"Validated")
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