IVD

Regulatory Strategy and Submissions: Guidance on regulatory requirements, including submissions to FDA (510(k), PMA), CE marking, and global regulations.

ISO 13485 Compliance: Ensuring quality management systems meet ISO 13485 standards for medical devices.

Biocompatibility and Risk Assessment: Developing risk management plans and conducting biocompatibility assessments as per ISO 10993 standards.

Clinical Validation: Support in designing and managing clinical trials to validate the performance of diagnostic devices.

Market Access: Assistance with market entry strategies, reimbursement policies, and pricing for global markets.

Product Development Support: Expert advice on assay development, validation, and optimization to ensure accuracy and sensitivity of IVDs.

Post-Market Surveillance: Setting up monitoring systems to track device performance and manage adverse event reporting.

Risk Management: Conducting risk assessments and ensuring compliance with ISO 14971 for medical device risk management.

Regulatory Audits: Preparing for regulatory audits by helping companies meet the required standards for documentation and safety.

Training and Knowledge Transfer: Providing in-house training on regulatory standards, risk management, and biocompatibility testing