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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