Industry Articles and announcements

For nearly three decades, medical device manufacturers preparing for a U.S. Food and Drug Administration (FDA) audit knew exactly what to expect. Investigators would arrive with the Quality System Inspection Technique (QSIT) handbook in hand, …

For nearly three decades, the United States medical device industry operated under the Food and Drug Administration’s (FDA) Quality System Regulation (QSR), codified in 21 CFR Part 820. Established in 1996, the QSR served as …

ISO 14155:2026, Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice, is now the global benchmark for medical device clinical investigations, replacing ISO 14155:2020 and redefining expectations for study design, conduct, and …

ISO 20417:2026, the newly updated standard for Medical Devices – Information to Be Supplied by the Manufacturer, aims to overcome common manufacturer challenges such as legacy labeling, inconsistent documentation, and outdated references. It’s a clear …

In highly regulated sectors like medical devices, aerospace, and construction, ASTM International industry standards are the bedrock of safety and quality. While voluntary, they are frequently incorporated into laws and regulations, building codes, and international …

Canada’s forestry industry faces serious challenges this year. Rising trade duties, wildfires, and restricted timber access are just the most recent developments in a precarious industry. However, despite all of the local challenges, a single …

While ASTM’s standards are voluntary, they are frequently incorporated into laws and regulations, building codes, and international trade agreements — making them obligatory for many businesses. Many products and contracts will even reference ASTM standards, …

In the rapidly evolving landscape of global manufacturing and engineering, access to ASTM International standards (formerly known as the American Society for Testing and Materials) is an operational necessity. Recently, the marketplace for these standards …

Written by Jonathan Brun, CEO When we first started Nimonik in 2008, we received a feature request from a large mining company. They asked that we create an auditable paper trail of their efforts to …

Medical device manufacturers operate in a complex regulatory environment where product design, manufacturing processes, and post-market activities are governed by a combination of regulations, technical standards, and regulatory guidance documents. Managing these requirements across multiple …

The aviation industry operates under a constantly evolving tapestry of global environmental regulations. For airlines committed to sustainability and operational excellence, keeping pace with this complex legal landscape is not just good practice—it’s essential for …

Following Accuris’s announcement to end their partnership with ASTM International, Nimonik is now the leading standards management platform that allows users to access all of their ASTM standards, non-ASTM standards, and additional documents in one …

Following Accuris’s announcement to end their partnership with ASTM International, Nimonik is now the leading standards management platform that allows users to access all of their ASTM standards, non-ASTM standards, and additional documents in one easy …

Following Accuris’s announcement to end their partnership with ASTM International, Nimonik is now the leading standards management platform that allows users to access all of their ASTM standards, non-ASTM standards, and additional documents in one easy …

Following Accuris’s announcement to end their partnership with ASTM International, Nimonik is now the leading standards management platform that allows users to access all of their ASTM standards, non-ASTM standards, and additional documents in one easy …

Written by Jonathan Brun, CEO of Nimonik As someone born in 1983, I grew up in the defining era of piracy — videogames, music, television, movies — you name it, we pirated it. Today, we …

Introduction This document outlines a high-level strategic blueprint for standards organizations to transition from a single-document retail model to a highly profitable, simultaneous-user subscription model. The core shift is moving from selling a physical “thing” …

The American Petroleum Institute (API) recently published API Advisory 9, which outlines the need for members of the API Monogram and APIQR Programs to hold active and current subscriptions to API publications. To obtain API …

The market for EHS regulatory compliance tools continues to consolidate with the acquisition of Swedish company Notisum AB and French company Echoline by the owners of Red-on-Line, InfoPro Digital. Press release is here. Since Red-on-Line …

Accuris, formerly IHS and Techstreet, recently announced that they will no longer offer ASTM standards as of the end of 2026. This is big news, since the American Society of Testing Materials (ASTM) is a critical …

Implementing an industry standards subscription can significantly benefit your organization by ensuring engineers, testers, and team members have access to the critical information they need. Making the transition from single purchases (retail) to an organizational …

Nimonik and ASTM International announced a renewed agreement to offer ASTM standards to organizations around the world through Nimonik’s compliance management software. This is big news, since Nimonik will become one of the only providers where you have the advantage …

After working in the compliance space for nearly 20 years, it is clear that a lot of company compliance agendas emulate a Potemkin village.  Potemkin village: A construction, either literal or figurative, that intentionally creates …

Learn how to build an effective regulatory change management framework to navigate evolving laws, reduce compliance risks, and maintain operational efficiency while avoiding fines and reputational damage.

In an era where regulations change at a dizzying pace, manual tracking can be a significant liability for organizations. While the top global regulatory compliance providers all enable customers to track regulatory changes, it can …

Learn how to build an effective regulatory change management framework to navigate evolving laws, reduce compliance risks, and maintain operational efficiency while avoiding fines and reputational damage.

In the changing landscape of engineering and manufacturing, choosing the right industrial standards partner is critical. Several providers may offer the essential standards documents that your organization requires, but it can be hard to identify …

Nimonik invites you to an exclusive webinar. Nimonik experts will discuss purchasing engineering industry standards and manage compliance. Learn how subscription models compare to retail options and discover how to navigate the complexities of industry …

As trade tensions mount and new federal measures — like the Buy Canadian policy — come into effect, it is an important time to highlight how Nimonik is the Canadian solution to US and European …

As trade tensions mount and new federal measures — like the Buy Canadian policy — come into effect, it is an important time to highlight how Nimonik is the Canadian solution to access engineering industry …

By: Jonathan Brun (CEO at Nimonik) I recently finished reading the fantastic book Next Generation Compliance by former EPA officer Cynthia Giles. While the book focuses on environmental regulations, most of its recommendations, ideas, and …

Effective June 1, 2024, IPC entered into a distribution agreement with Nimonik, a regulatory and standards compliance software company. Nimonik is now able to offer IPC standards products in hard-copy and electronic media format through …

Cary Coglianese has written an excellent paper on the interaction between Industry Standards and the Law. His main points are as follows: In short, standards and law are married – whether we like it or …

Montreal, QC – January 20th, 2024 – Nimonik is pleased to announce the appointment of Todd Fegan as a Strategic Advisor. Todd Fegan will help Nimonik develop and grow its offering of industry standards. Todd …

Nimonik expands into the United States with acquisition of Document Center, an industry standards reseller. Join Jonathan Brun and Kyle Bach as they discuss the integration process and enhanced features awaited by subscribers in this …

The Canadian Standards Association (CSA) has collaborated with the Western Regulators Forum (WRF) to make oil and gas standards more accessible to Canadian industry. The WRF is made up of the following regulatory authorities: Through …

Montreal, QC – January 10th, 2024 – To grow its support of the U.S. and international manufacturing and industrial sectors, Nimonik Inc. (Nimonik) announced the acquisition of Document Center Inc. (Document Center), a 41-year-old industry …

As the world’s largest developer of voluntary international standards, ISO (The International Organization for Standardization) aims to promote global material exchanges and mutual assistance, as well as to expand cooperation in knowledge, science, technology and …

In the ongoing effort to combat air pollution and promote environmental sustainability, the Environmental Protection Agency (EPA) has recently issued a supplemental proposal aimed at reducing air pollution in the oil and natural gas industry. …

ASTM Compass and Nimonik fulfill overlapping but distinct needs. ASTM Compass is designed for unique access to ASTM’s corpus, while Nimonik provides standards from 90+ publishers (including ASTM), as well as regulations and workflow tools …

The ability of companies to balance economic growth and adopt ethical and sustainable practices has become a non-negotiable for companies that want to keep up with the changing expectations of consumers and investors alike. In …

Join us for a day of insightful and interactive discussion with the Canada Energy Regulator. Date: September 20th, 2023 Location: Calgary Marriott Downtown Hotel Address: 110 9th Avenue SE, Calgary, AB T2G 5A6 Gathering Time: …

In today’s business landscape, adhering to regulatory standards is crucial for any company’s success and reputation. As Warren Buffet once said, “It takes twenty years to build a reputation and five minutes to ruin it.” …

Environment, Health, and Safety (EHS) regulations are constantly evolving. With new technologies, industries, and environmental concerns emerging, keeping up with the latest trends in EHS regulations is crucial for businesses to remain compliant and avoid …

Regulatory compliance is a critical aspect of any business. It ensures that companies follow laws, regulations, and standards that govern their industries. However, with the ever-changing regulatory landscape, compliance can be a challenge. Companies must …

June 20th, 2023 For Immediate Release Montreal, QC–June 20th, 2023– To grow its support of the Canadian manufacturing, industrial and consulting sectors, Nimonik announced the acquisition of the publications of Templegate Information Services Inc (Templegate)., …

As Health, Safety, and Environment (HSE) regulations continue to become more stringent, finding the right compliance tools and risk mitigation software has become essential. Companies need to have a robust and comprehensive EHS management system …

Overview Environmental Health and Safety (EHS) compliance audits ensure crucial workplace safety, environmental protection, and regulatory compliance. However, many companies are hesitant to undergo these audits due to concerns about the cost.  In this article, …

Managing environmental, health, and safety (EHS) can quickly become complex, especially when it comes to complying with regulations and mitigating risks within your organization. With constantly evolving legal requirements and compliance standards, it’s not always …

If you’re embarking on a compliance audit for the first time, a step-by-step guide can be an invaluable resource. A well-structured guide can help you plan your audit, keep you on track throughout the process, …

A compliance audit process is crucial to any business that wants to ensure it follows all relevant laws and regulations. These audits help companies identify areas where they may fall short and take corrective action …

One of the primary benefits of a compliance program is ensuring you operate within legal boundaries and mitigate potential risks or penalties. The advantages of using compliance software is the ability to become fully compliant …

BSB Edge Overview BSB Edge is an aggregator and distributor of standards and codes from 20+ Standards Developing Organizations (SDOs) with a focus on the Indian market’s needs. They have exclusive rights to manage and …

In an era where regulatory compliance, industry standards, and geographical regulations can make or break a business, finding a trustworthy platform to support your operations is paramount. Whether operating in a single industry or juggling …

ISO 37301 is a standard that helps organizations ensure compliance with legal and regulatory requirements while upholding ethical and social responsibilities. Implementing ISO 37301 can be a challenging but rewarding process for organizations looking to …

Obligation Management and Managed Obligations — the two concepts that are often confused, but have distinct differences. This article outlines how to differentiate them to effectively manage your obligations. In today’s complex business environment, organizations …

Compliance is essential for a successful and sustainable organization. A comprehensive compliance management system can help organizations comply with laws, regulations, and industry standards. Leadership, core values, and a positive culture of compliance are crucial …

In the rapidly changing and dynamic world, keeping abreast of current standards and regulations is paramount to success. Accuris and Nimonik are two companies that specialize in providing businesses with the resources and tools needed …

ISO 37301 Blog Post Series ISO 37301 replaces and improves on ISO 19600, what are the key differences? ISO 19600 and ISO 37301 are both standards that provide guidance on compliance management systems. However, there …

This new standard updates and replaces ISO 19600 and provides an excellent framework for compliance management in a modern organization. Introduction ISO 37301 is an international standard that sets out the requirements for establishing, implementing, …

In the rapidly evolving landscape of global manufacturing and engineering, access to ASTM International (formerly known as the American Society for Testing and Materials) standards is an operational necessity. ASTM’s library of over 13,000 active …

Organizations often purchase too much technology in the hopes it will solve their problems. The other extreme are organizations who do not implement anything out of fear of cost and complexity.  Introduction A new Nimonik …

Are you looking for a reliable platform for managing industry standards, regulations, and compliance requirements? Navigating the complex and ever-changing industry standards and specifications can be daunting, especially for businesses operating in multiple industries or …

Introduction Carnival Cruise Lines has a history of rough seas when it comes to environmental compliance programs. With over 60 million dollars in fines and after being placed in monitorship by the United States Department …

Between January 1st, 2022 and December 1st, 2022, 225 significant changes were made to regulatory documents that affect the Oil & Gas industry in Canada. There were other changes that are not covered in this …

Compliance with ever changing EHS regulations can feel like a non-stop marathon. With regulations constantly shifting and varying by location, staying on top of everything can be overwhelming. Managing audits and corrective actions for multiple …

Nimonik Inc. expands presence in Western Canada with acquisition of MediaLogic Inc. Montreal, QC–October 24, 2022 – Nimonik, a standards and regulatory compliance software solutions company, announced today it has acquired Calgary-based MediaLogic Inc. The acquisition …

RegScan Enhesa emerges as a trailblazer in the realm of compliance software providers and regulatory tracking platforms. With a rich history dating back to 1987, Enhesa has solidified its reputation as a trusted partner for …

Having a compliance management partner allows you as a company to be ahead and know all the regulations and compliances your company needs to meet. ENHESA competitors offer similar services, but each alternative has its …

Most organizations have a siloed approach to compliance with environmental, safety, quality, community engagement and other departments managing their compliance issues separately. Increasing fines, penalties and criminal proceedings for non-compliance are driving organizations around the …

EHS regulations and EHS standards exist to ensure organizations in specific industries maintain environmental compliance and workplace safety standards. The purpose of these regulations and standards is to incite behavior that would not otherwise occur …

Webinar Recording Webinar Slides Additional Resources Case Study: Implementing an advanced global auditing program at GKN Driveline a Tier-1 supplier Internal Quality Audit Best Practices based on the ISO 9001: 2015 Trascript JONATHAN: Good morning …