Media Coverage

Medical device reporting: Reading between the lines

Late last year, the U.S. Food and Drug Administration released the final guidance on Medical Device Reporting (MDR), a critical quality component of a company’s complaint management system. 
April 2017

3D Printing Meets Pharma: Reward & Risk

3D printing technology not only offers great potential to create drugs that are easier to consume and more effective, but also potential efficiencies throughout the research, development, and manufacturing process—even the supply chain.
March 2017

Data Integrity in the Medical Device Industry

Improving patient safety is at the heart of the medical device industry, but many manufacturers may not realize that this starts with data integrity in the manufacturing process. 
March 2017

Sparta goes all-in on cloud-based quality management systems

Pharmaceutical Commerce talks about the benefits automated validation for regulated industries.
February 2017

Lessons learned from a cookie dough recall​

Earlier this fall, several major brands voluntarily recalled products due to potential listeria concerns in cookie dough ingredients. 
January 2017

Medical device reporting: your burning adverse event questions answered

In November 2016, FDA released its final guidance on medical device reporting (MDR). MDR has been an intrinsic part of the medical device regulatory process for many years. There’s no specific change or new information in this document, but it does answer some fundamental questions about when and how to do things. It is organized as an FAQ-style reference, to be used in conjunction with online Medical Device Reporting requirements and guidelines.
January 2017

Preparing for IDMP Compliance – What you need to know

Beginning in early 2017, life sciences organizations that intend to manufacture and/or market medicinal products within the European Union will be required to comply with the Identification of Medicinal Products (IDMP) regulations, a global framework for identifying medicinal products, set forth by the European Medicines Agency (EMA).
January 2017

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