White Paper: Recycling of Food Contact Materials in the US, EU and Emerging Markets

This white paper provides a comprehensive overview of the regulatory landscape governing the use of recycled plastics in food contact applications in the United States and the European Union (EU).

White Paper: Cosmetics Regulations in the United States

This white paper looks at what is happening at the state level to oversee the safety of cosmetics and personal care products.

E-book: Managing Mycotoxin Risk in Food and Feed

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: EU Food Contact Regulations - Highlights of (EU) 2023/1442 & (EU) 2023/1627

Learn more about the 16th and 17th amendments of Commission Regulation (EU) No 10/2011 for plastic food contact materials ((EU) 2023/1442 and (EU) 2023/1627).

White Paper: Satellite™ Data Acceptance Program

Discover how Intertek's Satellite™ data acceptance program streamlines product safety testing and approval, reducing costs and time to market for manufacturers.

Unmasking Cyber Threats to Critical Infrastructure

Get insights into critical infrastructure vulnerabilities in the digital age. Explore energy, healthcare, and transportation sectors, and understand the growing threat of cyberattacks via the supply chain.

White Paper Download: "Evolution of the Home Healthcare Market and Medical Device Compliance"

The rise in home healthcare is shaping the future, impacting services and devices. Manufacturers must address differences in professional and home settings, understanding unique risks. Explore these variances in our white paper for compliance readiness and market advantage.

Testing & Compliance Requirements For Robotic Medical Devices

The widespread use and acceptance of robots across the healthcare industry is creating a number of opportunities for medical device manufacturers. It's also creating a number of questions when it comes to product testing and compliance. Our new FAQ answers many of those with help from our leading experts in regulatory compliance for medical robots.

White Paper: 5 Essential Steps to Medical Device Certification

The medical device industry relies on a higher level of documentation records than many other certification categories. It is important -- especially for start-up companies -- to consider that developing a functional prototype is NOT sufficient to meet the full regulatory burden. It is critical to generate all the documentation that covers the key elements of the IEC 60601-standard series, Food and Drug Administration (FDA) guidance, the Medical Device Regulation of Europe (MDR), and more.

Medical Device Market Requirements for Japan

The distribution of medical devices in Japan is regulated in accordance with the Pharmaceutical and Medical Device Act (PMD Act). The most recent revision to the PMD Act was made on August 1, 2021.

Medical Device Market Requirements for Brazil

Download our free Market Guidance Document for medical device regulatory requirements in Brazil. This guide outlines the compliance assessment steps in accordance with Ordinance 384/2020, the standard for the safety and performance of electronic medical equipment.

Download The Road to ‘Net Zero’ White Paper

In the urgent fight against climate change, the focus is on halting and not just reducing carbon emissions. With the Paris Agreement's 1.5°C target and 'net zero' goals, businesses and governments face mounting pressure to take action and be accountable for their carbon footprint.

White Paper: The Importance of Aligning a Pharmaceutical Audit Scope with the Correct Standard

Maintaining compliance and transparency in pharma supply chains is crucial. Quality audits of suppliers are vital to ensure high production standards. Choosing the right industry standard mitigates risk.

Brexit changes to the European Medical Devices Market

Brexit has had a widespread impact on many industries; the electrical medical device market has been no exception. Download our new overview of key requirements for placing a new medical device on the Great Britain (England, Wales, and Scotland) markets as well as the Northern Ireland market.

IEC 61010 Series: Master the Challenge & Keep Up with the Changes

IEC 61010 is a widely accepted electrical safety standard for laboratory, process control, and test & measurement equipment. This paper delivers an overview of the latest developments, new and revised requirements, the status of Edition 3 and Amendment 1 in major markets, and much more.

Case Study: Efficacy Assessment of Interdental Brushes Through In-Vitro Studies

Manufacturers of interdental cleaning devices are constantly striving to bring new and creative designs to market that have superior plaque removal and ease of use properties. To substantiate claims and provide evidence that these products are indeed effective, novel in vitro cleaning models can be fabricated used to evaluate and compare the efficiency of different brush designs to help guide the evolution of the most promising prototypes.

The Process Approach: Adding Business Value and Minimising Risks

Embrace the Process Approach as more than just compliance. It's a philosophy for efficient results. This whitepaper introduces tools like the Turtle Diagram and SWOT Analysis to support strategic objectives and foster an improvement mindset.

White Paper: Active Implantable Medical Devices

For Implantable Medical Devices, ensuring patient safety and device reliability is crucial. Our white paper, based on the 2018 webinar series, offers insights into meeting FDA and global regulatory standards effectively.

IEC/UL 62368-1 Safety of Information Technology and Audio/Video Equipment

The deadline is nearing and the countdown is on. For years the discussion around Dates of Withdrawal for 60950 and 60065 have been set, extended, and set again. At least, it appears we're ready to move on. Download our updated paper with information that will help you meet IEC/UL 62368-1 for IT Equipment and Audio/Video Products.

The ISO 45001:2018 Migration

Stay updated on OHSAS 18001 to ISO 45001 migration. Our whitepaper highlights key changes and explains the transition process for maintaining certified Occupational Health and Safety Management System Certification.

The European Food Contact Regulations

This whitepaper discusses recent changes in European food contact material regulations, focusing on amendments to Commission Regulation (EU) No 10/2011 for plastic FCMs. It covers key elements of the amendments and summarizes regulations for non-harmonized materials. Additionally, it outlines compliance steps and supply chain responsibilities.

IEC 60601-1-2 4th Edition EMC White Paper

The fourth edition of IEC 60601-1-2 introduces new product categories, new test levels, and eliminates the “life-support” device category from previous editions. Download our white paper to become familiar with the fourth edition requirements.

White Paper: Technologies to Measure Immunogenicity

This White Paper provides an introduction to Surface Plasmon Resonance (SPR) as a immunogenicity technology and a case study that compares both SPR and a bridging ECL format to detect anti-infliximab antibodies.

UAE ECAS Compliance: Manufacturer Guidance White Papers

UAE enforces ECAS for specific products. Intertek's white papers outline regulations and services for compliance, like ECAS Certificate of Conformity and EQM.

Epoxy Cure by Near Infrared Spectroscopy

In this white paper, you will gain insights into the epoxy cure process using near infrared spectroscopy. ​ The document explores the different chemical reactions involved in epoxy curing and how they impact the properties and performance of the cured resin. 

Polymer Rheology Testing Case Study: Supporting Formulation & Product Development

Polymer rheology testing aids in optimizing product formulations and process conditions. Case study highlights HA gel development benefits.

White Paper Download: Evaluation of Toothbrush Performance

In vitro methods enhance oral care product development, assessing toothbrush design for cleaning performance through the pellicle cleaning ratio test (PCR). Download the whitepaper to explore this testing approach's potential in comparing toothbrushes of varying designs.

White Paper: Requirements for Elemental Impurities Testing

This paper highlights the significance of testing for elemental impurities in the drug development process to ensure product safety. It discusses the importance of conducting risk assessments and adhering to applicable standards, particularly the USP <232> and USP <233> standards aligned with ICH guidelines.

Stationary Engine Generator Assemblies: Compliance to ANSI/UL 2200 & ANSI/ULC 2200

This fact sheet on ANSI/UL 2200 & ULC 2200 helps navigate certification questions for stationary engine generator assemblies, ensuring safe progress.

White Paper: The EU Biocides Product Regulation 528/2012

In 2012, the EU Parliament adopted the Biocidal Products Regulation (BPR to enhance the evaluation and authorization process for biocidal products. This regulation harmonizes rules for biocide availability and use, establishing criteria for active substances, product authorization, mutual recognition, and simplified procedures. By replacing directives with directly transposable and binding regulations, the BPR ensures uniform risk controls across the EU.

Trace Analytical Methods and Techniques for Testing Extractables and Leachables

Explore trace level analysis in pharma: critical for E&L testing. This white paper navigates standards, challenges, solutions, and case studies.

Extractables and Leachables Testing: An Introduction and Strategies in Current Practice

Our white paper explores E&L testing's importance in safeguarding drug product integrity. Gain insights, strategies, and benefits for seamless testing and market acceleration.

Patent Litigation and Product Liability: The Benefits of Partnering with a CRO

In cases of patent litigation or product liability, attorneys and consultants seek optimal outcomes for their clients by leveraging comprehensive resources, data, and expertise, as detailed in our white paper which outlines how engagement with a contract research organization (CRO) can deliver the necessary testing, analysis, and expert witness services for a successful resolution.

White Paper Download: Insight into Botanical Ingredients

Consumer preference for botanical cosmetics rises due to natural qualities and perceived efficacy. Extraction methods and bioefficacy play crucial roles, driving interest in ethically sourced products.

Glass Containers for Pharmaceuticals: Delamination and Interaction Studies

Glass delamination jeopardizes product quality; early evaluation via USP<1660>, predictive studies, and microscopy mitigates risks.

Polymer Rheology Case Study: Characterisation of the Physical Properties of Hyaluronic Acid Dermal Fillers

Polymer rheology testing links stress to material flow, crucial for product performance and optimization, saving costs, and minimizing waste.

IEC 60601-1-2 Edition 4: New Requirements for Medical EMC

Our experts developed this white paper to provide guidance on the new requirements and important changes of IEC 60601-1-2 Edition 4 and improve your speed to market.

Five Steps to Medical Device Commercialization in the United States

Bringing medical devices to the market in the United States is a complex process that requires an in depth understanding of all that is involved in classifying a device, preparing a premarket submission and submitting to the FDA. To help guide manufacturers through the process of bringing medical devices to the U.S. market, this whitepaper takes you step by step through the process of submitting your medical devices for approval from the FDA.

Top-8 FAQs of Failure Analysis

Failure analysis investigates the root cause of product, component, or asset failures. It offers insights to solve issues, take corrective measures, and prevent recurrence. Explore the top 8 FAQs for a better understanding of the process, including what it includes, why something broke, and its ability to pinpoint the exact cause.

Fast and Cost-effective Field Labeling of Medical Electrical Equipment

SPE 3000-19 serves as the model code for the field evaluation of medical electrical equipment (MEE) and medical electrical systems (MES), specifically pertaining to safety from electric shock, fire and mechanical hazards. This white paper provides all the information you need to fully understand the tremendous impact throughout the medical device industry, affecting manufacturers and distributors of medical equipment, doctors, hospitals, medical clinics and others.

Using ISO 9001 or ISO 14001 to Gain a Competitive Advantage

Join over 1.1 million certified organizations and leverage QMS/EMS for business growth, market-entry, and supplier relationships through ISO 9001 or ISO 14001 certification.

Radio Equipment Directive (RED) 2014/53/EU

Download this white paper for an overview of Radio Equipment Directive (RED) 2014/53/EU, its new requirements, and what it means for your next product design.

The Medical Device Manufacturer’s Guide to the RoHS 2 Directive

Our white paper provides a detailed overview of changes within the new Restriction of Hazardous Substances Directive (2011/65/EU), which has undergone major changes in terms of scope, definitions, and newly introduced methodologies and procedures.

The Recast RoHS Directive 2011/65/EU

Explore the major changes in the new RoHS Directive (2011/65/EU) in our white paper. Understand your obligations as a manufacturer, importer, or distributor, including demonstrating compliance for CE marking in the Technical Construction File.

Medical Electrical Equipment for the Home Healthcare Environment

Complete the form below to download Intertek's latest white paper on the 60601-1-11 series for medical electrical equipment used in home healthcare. This technical paper covers the new collateral standard, including scope, basic safety, and essential performance requirements, as well as instructions for use, environmental requirements, transportation and storage testing, and stricter classification requirements.

61010-1: Changes from 2nd to 3rd Edition

Intertek offers a side-by-side comparison of the new EN 61010 standard revisions to help you identify the key changes from 2nd to 3rd Edition. This sheet highlights changes within each Clause and details the scope expansion. From education to certification, Intertek provides expert guidance and industry-leading turnaround on testing to ensure compliance deadlines are met.