The COVID-19 pandemic has had a significant impact on the medical device industry. During this time, many medical devices became commercially available under enforcement policies, and…
The EU Medical Device Regulations (MDR) has been a looming, dark cloud of change for Medical Device Manufacturers. Whether the discussion is focused on the new…
What is the IVDR? An Overview The EU IVDR 2017/746 is the European Union In Vitro Diagnostic Regulation. This regulation is replacing the EU IVDD In…
The medical device market in the Asia-Pacific region has been growing year by year, with a 6.8% CAGR [1] due to an increase in the number…
What is the Medical Device Development Tools (MDDT) program? The FDA initiated the Medical Device Development Tools (MDDT) program to facilitate device development and the timely…
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…
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…
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…