White Paper Library

This white paper provides a comprehensive guide to Post-Market Surveillance (PMS) requirements under IVDR, detailing essential processes, documentation and compliance obligations for IVD manufacturers.

Explore FSMA 204's origin, growth, purpose, compliance and how we can help.

Download our latest ESG Research white paper to understand how the top 100 automotive organizations in North America report and prioritize sustainability.

Comparing the changes between ISO/IEC FDIS 27701 and ISO/IEC 27701:2019.

This white paper provides a comprehensive guide on demonstrating clinical performance under IVDR, covering key regulatory requirements, performance evaluation principles and essential documentation for compliance.

This white paper guides manufacturers through the transition from IVDD to IVDR, covering key regulatory changes, compliance steps and best practices.

This case study demonstrates how a leading medical technology company achieved ISO/IEC 27001 Information Security Management Systems certification to drive innovation securely.

Download our white paper to understand the information security challenges and solutions for the food industry.

Download our case study to discover how a growing Australian biotechnology company achieved Medical Device Single Audit Program (MDSAP) certification to expand their global market.

Delve into the depths of digital trust, its challenges, benefits and how we can help. Download our white paper.