Shining A Light on MDR Notified Body Standard Fees
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…
When to Start Preparing for the IVDR
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…
APAC (Asia-Pacific) Medical Device Regulatory Landscape
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…
Medical Device Development Tools (MDDT)
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…
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…
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…
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…
What Should (and Shouldn’t) Go In a Technical File for MDR?
European regulations require manufacturers to create and maintain a technical file as a prerequisite to submitting a Declaration of Conformity, allowing products to be CE marked.…