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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…
UKCA Mark Delay – How to Capitalize on the Extension
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…
MedTech Software Verification and Validation
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)…
Challenges of SaMD (Software as a Medical Device) Product Development
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) Audit Challenges
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…
Best Practices For a SaMD MDR Application
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…
FDA Q-Submission Program: What You Need To Know
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…
FDA eSTAR Program: Three Main Benefits
Medical Device companies are keenly aware of the difficulties and confusion that can surround medical device 510(k) and De Novo filings. With the Voluntary eSTAR Program,…
How To Prepare For Your First FDA Audit
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…
How To Prepare For Your First ISO Audit
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…