Understanding the FDA’s Final CDS Guidance
The Final Clinical Decision Support (CDS) Guidance, describes the FDA’s regulatory approach to Clinical Decision Support (CDS) software functions. Suffice it to say that much of…
The Final Clinical Decision Support (CDS) Guidance, describes the FDA’s regulatory approach to Clinical Decision Support (CDS) software functions. Suffice it to say that much of…
On October 21, 2022, the Medicines & Healthcare Products Regulatory Agency (MHRA) announced that they are adding a twelve-month extension to the current standstill period on…
Over the past decade, interest in innovating and commercializing medical devices has significantly increased. In the current trend of MedTech, Software as a Medical Device (SaMD)…
The trend of the software industry has been evolving throughout the years. In the past, projects were mainly about digitalization, rule based automation, and local server…
Software as a Medical Device (SaMD) is no longer an emerging vocabulary in 2022. With the rapid development of medical digitalization, medical devices are no longer…
Software as a medical device (SaMD) is a rapidly evolving field, posing opportunities and challenges for device organizations and regulators. We would like to dedicate this…
Medical devices have traveled a long path throughout the past century, and we certainly believe that there are many more miles to go in this ever-evolving…
More than a year ago, we explained the main benefits of the FDA eSTAR Program for 510(k) and De Novo filings. This information remains accurate, and…
The FDA just called notifying you of their upcoming site visit! Now what? An FDA Inspection Audit can occur at any time. Below are tips you…
Overview of ISO 13485:2016 ISO 13485:2016 is the industry standard for quality management systems for medical devices. Medical device specification developers, manufacturers, and distributors seek certification…