Knowing these intricate regulatory pathways is essential to making sure a easy acceptance procedure and avoiding high priced delays.
Many my operate is in an authority witness position wherever I perform closely with Lawyers to offer unbiased opinions and establish equally the strengths and weaknesses of a shopper’s scenario.
DDReg can be a premier consulting business specializing in medical devices, supplying expert answers to navigate the complexities of regulatory requirements. Our consulting expert services help manufacturers in accomplishing regulatory approvals, employing quality administration methods, making sure market place access, and conducting write-up-industry surveillance, therefore guaranteeing global compliance.
I've substantial working experience rescuing medical trials and FDA submissions at risk of failure resulting from compliance and content material problems.
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Due to this fact, certification is necessary to be sure their ongoing marketability. The introduction of classification principles also necessitates the involvement of the notified body for your overwhelming majority of in vitro diagnostic medical devices. A quality management process in accordance with ISO 13485 is required in the two circumstances. We help manufacturers to successfully and proficiently meet up with the necessities of the Laws on Medical Devices and IVDs.
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Development and acceptance of medical devices, article-internet marketing surveillance
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I'm an FDA regulatory specialist witness and an FDA compliance advisor proficient while in the regulations and submissions of prescription drugs, biologics and medical devices.
They understand how to harmony the advantage-hazard ratio With all the practicalities of regulatory compliance. Because NAMSA performs preclinical studies, medical research and screening on thousands of medical devices and IVDs annually, our consultants arrive at Each and every challenge having a very well-informed feeling of just what the US FDA, European Notified Bodies and other regulators assume to check out.
We are the Skilled Get hold of for all questions that occur with regard to marketplace demands, medical devices directives and particularly The brand new EU regulations on medical devices.