2025
Home Healthcare Medical Devices | FAQ
The home healthcare market offers significant opportunities but also complex compliance and safety challenges for manufacturers. Download our new FAQ sheet "Safety and Performance Compliance For Home Healthcare Medical Devices" to learn more.
Six Compliance-Related Questions About Connected Home Healthcare Devices | White Paper
The home healthcare market is growing rapidly and device manufacturers are developing new innovations to improve patient care. Launching connected devices in the home. Download our white paper that addresses six compliance questions about connected devices in the home.
UL 60335-2-40 Latest Requirements for Certification
Big changes are here for HVAC/R manufacturers and professionals. As of January 1, 2025, UL 1995 is officially replaced by UL 60335-2-40. Are you fully prepared? Download our free white paper for answers to the most pressing questions.
CSDDD & CSRD – Step-by-Step Guide to Align Compliance Efforts for the EU’s Directives
EU Member States and Parliament approved the ‘Stop-the-clock' directive this week, which delays reporting requirements under CSRD and CSDDD as part of the proposed Omnibus simplification package. Despite this announcement many companies still need to continue working towards CSRD and CSDDD compliance.
IEC 60601-2-10 Edition 2.2 (2023) | FAQ Paper
To ensure a smooth transition from IEC 60601-2-10 Edition 2.1 to Edition 2.2, Intertek's medical device experts have created a comprehensive Q&A document clarifying these essential updates and regulatory implications. Download your copy and confidently navigate this important regulatory update.
AI-Enabled Medical Device Development | FAQ Paper
Intertek's new guide, "Key Questions for AI-Enabled Medical Device Development," addresses essential factors of Artificial Intelligence (AI) and Machine Learning (ML) for Medical Devices including: clinical problem definition, representative test data, transparency of AI decisions, cybersecurity, and model validation.
White Paper: Is My Substance A Polymer?
This whitepaper examines the OECD's 1993 definition of a polymer, widely adopted by regulatory agencies in Canada, Australia, the US, and the EU.
Whitepaper: Adopting AI-Driven Solutions
In a rapidly evolving market, leveraging AI is key to maintaining a competitive edge. Our whitepaper provides actionable insights into how AI can revolutionise your workflows, from automating routine tasks to optimising supply chains and enhancing decision-making processes. Key Outcomes: - Gain a thorough understanding of AI’s potential and its practical applications. - Learn how to address and mitigate security and compliance challenges effectively. Download the whitepaper now to start harnessing AI for greater productivity and security in your organisation.
EU General Product Safety Regulation (GPSR): A Comprehensive Guide
Explore our comprehensive whitepaper on the General Product Safety Regulation (GPSR), designed for those unfamiliar with this crucial EU regulation. Learn about compliance requirements, key provisions, and some common questions to ensure consumer safety in the evolving regulatory landscape.
E-book: Managing Mycotoxin Risk in Food and Feed: updated February 2025
Mycotoxins are toxic compounds produced by certain types of fungi. These fungi and the toxins they produce can contaminate a variety of food and crops, including nuts, cereals, and spices, posing a serious threat to human and animal health. Our e-book explores the dangers of mycotoxins in food, how to test for them and more.
White Paper | Analytical Approaches For Control of Genotoxic Impurities
Understand the importance of controlling genotoxic impurities in pharmaceuticals and strategies to manage their risk effectively.
IEC 61439 Series Update: Low Voltage Switchgear & Controlgear Assemblies
Learn how IEC 61439 Edition 3.0 affects product compliance in power switchgear in our white paper, covering key 2020 changes.
White Paper Download: Material Characterisation for the Automotive Supply Chain
In the competitive automotive industry, reliability and durability of components and parts are essential for timely product launches. Suppliers must complete a series of validation tests to demonstrate the reliability and durability of materials and parts. By understanding common pitfalls and validation test planning challenges, product development teams can reduce delays, improve product launch timelines, and mitigate the effects of product failures during testing.