COMPANY PROFILE

White Lab Medical Devices Division offers comprehensive services to support the entire lifecycle of medical products, from development to market entry:
• Conformity assessment of your MD to international standard
• Risk Analysis, BEP, BER, Gap Analysis, Toxicological Evaluation, Clinical Evaluation Report
• Technical documentation writing
• Use and Maintenance Manual, Technical File
• Testing of your Medical Device
• In vivo and in vitro testing, Chemical Characterization, Detection of Extractable and Leachables and Microbiological testing, Sterilization and Reprocessing Validation, Electromagnetic compatibility, Electrical safety, Radio testing, Validation of software, Cybersecurity
• Full audit assistance and certification
• Consultancy for Medical Certification inside and outside UE
• Quality system procedures assistance
• Audit to check system compliance
• Our highly skilled team and state-of-the-art laboratories provide reliable and timely results, making us a trusted partner in the healthcare sector.