Medical Device Cleaning Validation

Leave a Comment / Blog, Client Questions, EU Regulations, Guides and Advice, Medical Device Post-launch, Medical Device Pre-launch, Medical Device Validation, Quality Assurance, UK Regulations /

Cleaning validation is a critical process for ensuring the safety and effectiveness of medical devices by verifying that they are free from harmful contaminants such as biological residues, chemical remnants, and particulate matter. This process is essential for meeting stringent regulatory standards, including ISO 13485, ISO 14971, EU MDR, and FDA guidelines, which mandate thorough cleaning protocols to mitigate risks to patients and device functionality. By defining acceptance criteria, conducting risk assessments, and performing robust validation testing, manufacturers can establish consistent cleaning processes that meet compliance requirements.

Medical Device Cleaning Validation Read More »