THANK YOU
Your request has been successfully submitted.
To complete your submission, please open the confirmation email that we just sent you, and click on the link.
EUDAMED Update: What You Need to Know Now
The European Union (EU) Medical Device Regulation (MDR) officially went into effect in May 2021, while the In-Vitro Device Regulation (IVDR) took effect in May 2022. The new legislation established the creation of EUDAMED, an online repository of information intended to streamline access to data for regulators, medical professionals and the public. Pandemic-driven delays, however, […]
AssurX Names Stephanie Ojeda as Director of Product Management for Life Sciences Industry
Morgan Hill, CA., June 22, 2022 — AssurX, Inc. (AssurX), a leader in quality management and regulatory compliance software, today announced the appointment of Stephanie Ojeda as Director of Product Management. Ojeda will be responsible for overseeing the development and innovation of the AssurX QMS platform for the life sciences and manufacturing industries. “We are thrilled […]
5 Ways an EQMS Resolves Change Management and Change Control Pains
In the life science industry, adjustments are a necessary element throughout the product lifecycle. From R&D through post-market, changes both big and small are inevitable in documents, requirements, and processes. For this reason, change management is embedded in Good Manufacturing Practices (GMP) as laid out in FDA regulations and ISO standards. Many things can trigger […]
Why Calibration Management Software is Key to Proactive Quality
Unplanned downtime is an expensive issue, costing companies $50 billion every year, according to research by IndustryWeek and Emerson. Nearly half of this downtime is the result of equipment failure, indicating that more proactive strategies are necessary to keep machinery running smoothly. Effective calibration management is a key part of maintaining uptime and avoiding product […]
EU Medical Device Regulation Still Presents Challenges and Opportunities
EU Medical Device Regulation (MDR) has been in effect for almost a year. As anticipated, the regulation has proven to be as challenging as the industry expected it would be. Now, companies also have to establish compliance with the upcoming implementation of the In Vitro Diagnostic Medical Devices Regulation (IVDR). Device firms have been preparing […]
Food Industry FSVP Violations Revealed in FDA Warning Letters
In recent months, the U.S. Food and Drug Administration (FDA) has issued a dozen warning letters over Foreign Supplier Verification Program (FSVP) violations. These food industry FSVP violations underscore the increasing eye on the risks to public safety within the global supply chain. Part of the Food Safety Modernization Act (FSMA), the FSVP requires manufacturers […]
How to Overcome Quality Management Review Challenges
This is the second installment of a two-part series focusing on the importance of a quality management review for companies in regulated industries. One of the most important parts of any enterprise quality management system (EQMS) is the quality management review (QMR). If you work in a regulated or ISO-certified organization, QMR is a requirement. […]
What is a Quality Management Review and Why Do You Need Them?
This is the first installment of a two-part series focusing on the importance of a quality management review for companies in regulated industries. What is a quality management review (QMR)? A QMR is a formal process for assessing the performance of a company’s quality management system (QMS). The aim of the review is to assess […]
Understanding FDA Alignment of ISO 13485 with Quality System Regulation
The FDA’s official proposal to align its Quality System Regulation (QSR) with ISO 13485:2016 was long in coming, but worth the wait. Regulatory authorities consider it necessary to improve medical device safety and availability. With the device market projected to reach $657.98B by 2028, the evolution seeks to further harmonize standards in a global market. […]
FDA Warning Letters Highlight Food Safety Compliance Issues
The U.S. Food and Drug Administration (FDA) has issued dozens of warning letters to date in 2022, also announcing resumed inspections after pausing them amid the Omicron surge. Furthermore, a review of recently posted FDA warning letters highlights a strict approach to enforcement, especially for repeat violations. The emerging implications for the food industry are […]
We're proud to keep good company
