In Vitro Diagnostics (IVD)

WOAB provides specialized auditing, assessment, and certification services for the In Vitro Diagnostics (IVD) industry. With extensive technical expertise and a thorough understanding of regulatory requirements, we help manufacturers strengthen quality management systems, achieve compliance, and maintain the highest standards of product quality and patient safety.

WOAB supports in vitro diagnostics (IVD) manufacturers with specialized auditing, consulting, and compliance services throughout the product lifecycle. With extensive industry expertise, our team understands the regulatory and operational challenges involved in developing, manufacturing, and maintaining compliant IVD products.

Our comprehensive solutions help organizations navigate evolving regulatory requirements, strengthen quality management systems, improve manufacturing compliance, and support successful market access. From product development to post-market compliance, WOAB works with manufacturers to enhance quality, reduce regulatory risks, and maintain adherence to applicable international standards.

Services

Participation in WOAB consulting or training services is separate from the certification process. The use of these services does not provide any competitive advantage, influence certification decisions, or guarantee the granting of certification.

Audit & Inspection Readiness Services

WOAB provides comprehensive audit and inspection readiness services to help manufacturers prepare for every stage of the assessment process. Our experienced auditors conduct detailed gap assessments, mock audits, and compliance evaluations to identify potential issues, strengthen quality management systems, and improve readiness for regulatory and certification audits. We help organizations minimize compliance risks and maintain continual inspection preparedness.

Outsourcing Services

WOAB offers specialized outsourcing solutions to support manufacturers across key regulatory and quality functions. Our services include assistance with clinical trial support, regulatory documentation and submissions, quality management activities, and compliance programs. By leveraging our industry expertise, organizations can optimize internal resources, improve operational efficiency, and maintain compliance with applicable national and international standards.

Regulatory & Quality Support for Life Sciences Legal Teams

WOAB collaborates with legal teams to provide independent regulatory and quality support across the life sciences sector. Our experts assess regulatory risks, identify and remediate compliance gaps, and assist with mergers, acquisitions, and due diligence activities involving pharmaceuticals, medical devices, in vitro diagnostics (IVDs), biotechnology, and biologics. Our services help organizations make informed decisions while strengthening compliance and reducing business risk.

Regulatory Services

WOAB provides comprehensive regulatory support to help medical device and in vitro diagnostics (IVD) organizations establish and maintain compliant, effective, and sustainable quality management systems. Our team of experienced regulatory professionals and technical specialists helps organizations navigate complex requirements, strengthen compliance frameworks, enhance product safety, and support successful market access.

ISO/IEC 42001 Artificial Intelligence Management System (AIMS) Certification

Implement a responsible and structured approach to artificial intelligence governance with ISO/IEC 42001 certification. Strengthen organizational resilience, manage AI-related risks and opportunities, enhance trust in AI systems, and support the effective, ethical, and secure use of artificial intelligence technologies.