solutions regulations eu-mdr 
QAD
MAY 18, 2021
The EU Medical Device Regulation (MDR) is set to take effect on May 27, 2021. The EU MDR replaces the EU Medical Device Directive (MDD) , and the replacement of the word “directive” with “regulation” tells the story. New MDR Definitions for “Medical Device”. What Will Change?
Unleashed
OCTOBER 27, 2020
Regulations and Medical Device Manufacturing in 2021. Historically regulation of medical devices has lagged the more tightly controlled pharmaceuticals industry. The European Union’s Medical Device Regulation (MDR) – formally known as Regulation (EU) 2017/745 – which sets out rules for medical devices sold in the EU.
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Arena Solutions
AUGUST 4, 2021
To meet these goals, many organizations rely on enterprise quality management system (QMS) software solutions to get high-quality products to market fast. More and more organizations rely on a QMS to meet FDA, EU MDR, and ISO regulatory standards and reduce audit risks and consequences. The History of QMS. ISO 9001 Compliance.
Arena Solutions
SEPTEMBER 12, 2023
Software vendor reference checks can reveal how well the solution lives up to the vision marketed and sold. Yet, with the right questions, you can figure out whether the solution is the best fit for your business. Medical device companies: What FDA / EU MDR classification is assigned to your product? What modules (e.g.,
QAD
JULY 15, 2021
Here are some of the top trends we’re seeing in the life sciences industry post-pandemic: Regulatory : Though new regulations were in progress before COVID, some were delayed, such as the EU MDR and EU iVDR requiring full product traceability from packaging, labeling and manufacturing to post-market and end patient use.
Arena Solutions
DECEMBER 16, 2020
All our customers, no matter industry, maturity, or complexity, have had to answer the same question: when to implement a scalable software solution to manage the enterprise processes that run the businesses. We track what drives our customers to buy a solution at the point in time they do—their timing drivers.
Arena Solutions
MARCH 9, 2023
Here, we provide a glimpse of what you can expect at LiveWorx and highlight some of the sessions surrounding Arena’s cloud-native product lifecycle management (PLM) and quality management system (QMS) solutions. Attending LiveWorx is a great way to see how other companies are using digital solutions to streamline their product work.
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