Validation of a Medical Device

Our team of experts assist with your validation needs, starting with a Master Validation plan, through to developing protocols, and executing and finalising reports:

• Medical Device Software - Computer Software Validation
• Medical Device Packaging - Package Integrity & Sealing Validation
• Medical Device Sterility, Reprocessing & Cleaning
• In Vitro Diagnostics - Assay Validation & Clinical Reference

Training and Education: Tailoered training programmed on IVDR and regulatory aspects. Continuous training to adapt to any changes in regulations.