Post-market Surveillance (PMS), in the context of Quality Management Systems (QMS), refers to the systematic approach to collecting, recording, and analyzing data on the quality, performance, and safety of a medical device throughout its entire lifecycle, actively and continuously. This process is an integral part of a manufacturer’s QMS.
- March 15, 2024 Medical Devices
- March 15, 2024 Medical Devices
21 Code of Federal Regulations (CFR) Part 820, also known as the Quality System Regulation (QSR), is part of the United States (US) CFR that establishes the criteria under which medical devices are manufactured. It covers various aspects of the manufacturing process, including design, production, labeling, storage, installation, and servicing of medical devices.
- March 14, 2024 Food and Food Supplements, Chemicals, Cosmetics Regulatory Services
In recent years, consumer preferences have shifted towards eco-friendly products, impacting chemical product registration and compliance. Sustainable packaging is now a crucial focus for manufacturers and regulators, influencing the entire supply chain.
- March 14, 2024 Chemicals, Regulatory Affairs
In the ever-changing world of consumer safety, regulations are crucial for protecting people and households. The European Council's introduction of the General Product Safety Regulation (GPSR) in May 2023 is a significant advancement in this effort.
- March 14, 2024 Chemicals, Regulatory Affairs
In the chemical industry, consumer product safety reigns supreme. Yet, even the most diligent manufacturers can face unforeseen circumstances that lead to product recalls. Whether it's a labeling error, a potential hazard, or non-compliance with regulations, navigating a recall can be daunting.
- March 7, 2024 Publishing & Submissions, Regulatory Software & Services
The fast-evolving and dynamic environment of the pharma industry calls for an equally active and quick technology. There is a rise in compliance technology due to various factors like robust regulatory adherence and efficiency in medical operations.
- March 5, 2024 Regulatory Artwork Services
Navigating the intricate world of Regulatory artwork can feel like walking a tightrope. One misstep, one non-compliant label, one inaccurate diagram, and the consequences can be severe. Delays in product approvals, costly fines, reputational damage - the price tag of non-compliance can quickly spiral out of control.
- March 5, 2024 Regulatory Artwork Services
The pharmaceutical industry finds itself amidst a dynamic and ever-evolving Regulatory landscape in 2024. Navigating these shifting currents necessitates a focus on compliant and effective artwork, which serves as a critical tool for ensuring both Regulatory adherence and brand success.
- March 5, 2024 Publishing & Submissions, Regulatory Software & Services
In a recent development, the Therapeutic Goods Administration (TGA), Australia has updated its guidance document titled “eCTD AU Module 1 & Regional Information,” making crucial changes to Module 1 v3.1 while adopting the International Council for Harmonization’s (ICH) electronic Common Technical Document (eCTD) v4.0 specification.
- March 4, 2024 Food and Food Supplements
Singapore’s food industry is currently undergoing a major Regulatory transformation, particularly with respect to infant nutrition. The Singapore Food Agency (SFA) has proposed a set of amendments, with a specific focus on infant formula additive regulations, aiming to elevate the safety and quality standards of infant nutrition products.