Validations

The pressure to meet stringent ISO and FDA standards while maintaining product integrity and patient safety is constant. You need confidence that your packaging, sterilisation, and cleaning validations are executed to the highest standard, and that every step is documented thoroughly, accurately, and in line with your product’s specific requirements. That’s where Eurofins Sterile Packaging can help. 

With decades of experience, state-of-the-art facilities, and an expert team of validation professionals, we offer end-to-end solutions tailored to your product configuration and regulatory market. Our validation processes are designed to meet all required specifications and, together with thorough qualifications, ensure consistently high product quality. Each step is extensively documented, providing the evidence needed to support product approvals. We also offer tailored validation services based on individual requirements. Whether it involves cleaning, packaging, sterilisation, or mechanical strength, we deliver all necessary validation steps with regulatory documentation.

Documentation

We understand that validation must be both technically robust and audit-ready. Our team ensures a consistent high quality by implementing our quality management EN ISO 13485 in every step. We document each stage of the process according to the validation requirements and make this documentation available to our customers.

The European Medical Device Regulation (MDR 2017/745) introduces new requirements for medical device manufacturers, as well as their suppliers and subcontractors. To ensure compliance, we have thoroughly reviewed the MDR requirements and updated our process documentation and verification records accordingly. This structured, MDR-aligned documentation simplifies the approval process for our customers. All documents are prepared in English as standard. Translations into other languages can be arranged upon request.