Medical Device Regulatory & Engineering Blog

In the world of clinical trials, being organized and keeping accurate documentation is essential. Every detail, from the initial planning stages to the final results, ...

Failure Mode and Effects Analysis (FMEA) is one of the most wide-spread methodologies within medical device risk analysis. In this article, we explore the nuanced ...

Both the FDA 21 CFR 820 and ISO 13485 mandate that medical device companies undertake internal audits. They constitute an integral component of any effectively ...

Medical device manufacturers are required to integrate a corrective and preventive action (CAPA) into their quality management systems (QMS). Investigations and violations of CAPA systems ...

Working your way through the regulatory landscape can be a daunting task, and among the many requirements and approvals, two terms stand out: 510(k) and ...

The FDA's Global Unique Device Identification Database (GUDID) is now fully operational, marking a significant milestone in medical device regulation. For medical device manufacturers gearing ...

The US FDA has several approval and clearance routes that allow medical devices to be marketed in US territory. Based on risk-based classification, there are ...

Each medical device has a unique journey, intricately documented in its Device History Record (DHR). The DHR highlights the design documentation to completely document the ...

Any business or organization must ensure the quality of products or services to be efficient and competitive. In the highly regulated field of medical devices, ...