A Guide to Risk-based Thinking in IATF 16949
This document discusses risk-based thinking, implementation and improvement considerations as well as risk-based thinking in ISO 9001 and IATF 16949.
Comparison of GDPR and Privacy Laws in China and Hong Kong
This white paper provides a comparison of GDPR against the Personal Data (Privacy) Ordinance (PDPO) in Hong Kong ,the Personal Information Protection Law (PIPL) in China and the robust privacy management frameworks of ISO/IEC 27701:2019 and ISO/IEC 27018:2019.
Nitrosamine Control: Understanding the New FDA and EMA Regulations
This technical bulletin discusses major regulatory updates, introduced by the FDA and EMA, regarding nitrosamines and our proposed risk assessment method for compliance.
A Guide to the Requirements and Changes to ISO 24444:2019 – In Vivo Determination of the Sun Protection Factor (SPF)
On December 19, 2019, a new edition of ISO 24444 – in vivo determination of the Sun Protection Factor (SPF) was published. This guide summarizes the requirements and major changes.
Standard vs. "Hybrid" FIH Trial Advantages and Challenges
This white paper examines the key considerations to take into account when deciding whether to run a standard first-in-human study in healthy volunteers or a hybrid FIH clinical trial.
Convergence of Rewet Data in Nowadays' Baby Diapers
This update aims to provide more information about how SGS uses rewet data (following ASH-R methods) to test nowadays' baby diapers.
CE Marking of Construction Products, Today and Tomorrow
This white paper is intended for anyone who deals with CE marking of construction products and wants to know more about the applicable regulations for these products.
A Guide to Successfully Navigating China’s New Cosmetics Import Regulations
As of May 1, 2021, global cosmetic brands looking to sell their products in China will have to abide by the new regulations. This guide will explain how you can comply.
Maxims for Early Phase Trials
This white paper considers the importance of conducting safe, efficient, and productive early phase clinical trials and the options that are available to developers for study optimization.
An Updated Approach to Extractables and Leachables Testing per ISO 10993–18:2020
Medical devices must not adversely affect a patient’s safety. ISO 10993-18:2020 outlines how medical device manufacturers can test their products for potentially harmful chemicals leaching from the device materials.