Discover the essential steps for medical device manufacturers to ensure FDA regulatory compliance and quality standards.
Quality and Regulatory Compliance within the medical device industry has become increasingly complex. FDA, as well as the various international...
On November 17, 2023, FDA published a new guidance document titled “Assessing the Credibility of Computational Modeling and Simulation in Medical...
The introduction of new and complex regulations, combined with the need to get safe and effective devices approved and into the market as quickly and...
With the release of the latest ISO 13485 version in March of 2016, Quality Management Systems (QMS) became a primary focus within the medical device...
The automotive industry has certainly had its share of challenges over the past three years. The COVID-19 pandemic, supply chain issues including...
The introduction of EU 2017/745 (“EU MDR”) has brought about significant changes within the medical device industry. The fundamental landscape of our...
