Biological Safety

Biological Safety, also known as biocompatibility, is crucial in ensuring that medical devices are safe for patient use. This service involves a comprehensive evaluation of the materials used in the device, ensuring they do not cause any adverse reactions. 

With a vast array of materials like metals, ceramics, and polymers, it’s essential to have a detailed safety plan that mitigates risks and adheres to strict regulatory standards. Ensuring biological safety is not just about compliance but about protecting patients' well-being. If you’re developing a new medical device or updating an existing one, contact us to create a robust biological safety plan that ensures your product is safe for market release.

List of Services:

• Biological Safety Evaluation Plan
• Biological Safety Summary Report
• Toxicological Risk Profile
• Analysis of Adverse Findings
• Gap Analysis vs Recognized National and International Standards
• Biological Safety QMS Development
• On site training
• Regulatory Toxicology
• Biological Safety Regulatory Issues