Secure validation programs for a safe medical device
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.
puracon can 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
All packaging tests are available with our in-house testing services:
- Packaging OQ/PQ
- Shelf-life testing
Validations, time and cost efficiency – we help you to combine these
The field of validations is wide and a lot of time and money can be wasted when the validation program is not the right one for your product. With our extensive experience in validations and validation programs, we can help you establish a validation program that proves safety and functionality of your products – and is time and cost efficient.