Audits against the international standard for medical device quality management systems, ensuring compliance and certification readiness.

KEY BENEFIT: Facilitates global market access and regulatory approval.

Audits focused on the general quality management system (QMS) requirements applicable to all industries, including medical devices.

KEY BENEFIT: Drives continuous improvement and operational excellence.

Audits aligned with the FDA’s evolving Quality Management System Regulation, harmonised with international standards.

KEY BENEFIT: Ensures readiness for upcoming regulatory changes and harmonisation.

Audits that meet the requirements of the Medical Device Single Audit Program, allowing recognition by multiple regulatory authorities.

KEY BENEFIT: Streamlines compliance for multiple markets with a single audit.

Audits to ensure compliance with the European Union Medical Device Regulation, essential for market access in the EU.

KEY BENEFIT: Enables continued sales and distribution in the European market .

Audits for compliance with the United Kingdom’s medical device regulations supporting continued market presence post-Brexit.

KEY BENEFIT: Maintains regulatory approval and market continuity in the UK.

Country-specific audits to address unique regulatory requirements for medical devices in these key markets.

KEY BENEFIT: Maintains regulatory approval and market continuity in these key markets.

Audits focused on software lifecycle processes for medical device software, ensuring compliance with this critical international standard.

KEY BENEFIT: Reduces risk and enhances quality for medical device software development.

Audits to ensure compliance with policies, processes, and controls in place to protect sensitive information, identifying nonconformities and areas for improvements, and ensuring that the Information Security Management System (ISMS) aligns with both the standard and best practices.

KEY BENEFIT: Helping organisations ensure their Information Security Management System (ISMS) is effective, compliant with international standards, and capable of protecting sensitive information against evolving threats, thereby reducing risks and building trust with clients, partners, and regulators.

Audits focused on risks associated with medical devices throughout their lifecycle ensuring patient safety and regulatory compliance.

KEY BENEFIT: Ensures risks associated with medical devices are systematically identified, evaluated, controlled and monitored, which supports patient safety and regulatory compliance throughout the product lifecycle.