Validation of Medical Devices
Medical devices demand the highest degree of safety, functionality and efficiency. A well planned and performed validation program is the basis for a safe and efficient product and a successful product approval.
Cosmo Meditec will support you not only in setting up a product-based validation program, but also in organizing and performing the selected validation program in-house or with expert partners. Our experience does not end at validations, but also covers all quality topics - from audits and CAPAs to nonconforming products and complaint handling. Our experienced and well-trained employees are ready to consult with you on these topics.
Besides the consultancies, we can write a validation report as part of technical file for CE submission, CSDT and so on. We work under the international standards. We therefore understand your need and are able to provide you with state of the art documentation.
We do not only provide you the tests, but also support you with full services as a partner offering training and consultancy.
Cosmo Meditec will support you not only in setting up a product-based validation program, but also in organizing and performing the selected validation program in-house or with expert partners. Our experience does not end at validations, but also covers all quality topics - from audits and CAPAs to nonconforming products and complaint handling. Our experienced and well-trained employees are ready to consult with you on these topics.
We cover all validations to prove conformity, efficiency and safety of your product:
- Cleaning validation
- Packaging validation
- Sterilization validation
- Transportation validation
- Facilities qualification
All packaging tests are available with our in-house testing services:
- Packaging OQ/PQ
- Shelf-life testing
Besides the consultancies, we can write a validation report as part of technical file for CE submission, CSDT and so on. We work under the international standards. We therefore understand your need and are able to provide you with state of the art documentation.
Packaging test
- Visual inspection test | ASTM F1886
- Peelability test | EN 868-5
- Dye penetration test | ASTM F1929
- Seal strength test | ASTM F88
- Accelerated aging test | ASTM F1980
We do not only provide you the tests, but also support you with full services as a partner offering training and consultancy.
Applicable Standards
- ISO 13485
- ISO 11607
- ISTA
- ASTM
- EN
- USP
