Medical devices

Regulatory Compliance: Assisting with FDA, EU MDR, and other global regulatory requirements for medical device safety and risk management.

Risk Management: Developing and implementing risk management processes as per ISO 14971 to identify and mitigate potential hazards associated with medical devices.

Biocompatibility Assessments: Advising on biocompatibility testing and strategies in compliance with ISO 10993 standards.

Safety Data Analysis: Reviewing post-market surveillance data, adverse event reports, and field data to monitor product safety.

Human Factors and Usability Engineering: Ensuring device safety through usability studies and human factors analysis to minimize user error.

Preclinical and Clinical Study Design: Advising on safety protocols for preclinical and clinical trials, including study design, monitoring, and reporting.

Toxicological Risk Assessments: Evaluating the safety of device materials, including extractables and leachables, to ensure biocompatibility.

Post-Market Surveillance: Developing strategies for continuous monitoring of devices in the market, including complaint handling and safety reporting.

Product Lifecycle Safety Support: Providing safety oversight from the design phase to post-market monitoring to ensure compliance with regulatory safety standards.

Audit Preparation and Support: Preparing companies for regulatory audits focused on device safety and addressing any safety-related deficiencies