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Incredibly professional and seasoned consultants to operate with. Documents developed by NAMSA consultants are published in a really substantial conventional.
With above a decade of pioneering abilities from the regulatory consulting, DDReg stands out to be a trusted spouse for medical device marketplace...
I have significant encounter rescuing clinical trials and FDA submissions at risk of failure due to compliance and content issues.
Empower your regulatory journey with DDReg’s Toxicology Methods. DDReg provides a broad spectrum of toxicology and risk assessment remedies designed to deal with complicated protection and compliance challenges.
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Because of this, certification is essential to be sure their continued marketability. The introduction of classification policies also necessitates the involvement of a notified overall body for your overwhelming majority of in vitro diagnostic medical devices. A high quality administration program in accordance with ISO 13485 is required in both conditions. We assistance companies to effectively and proficiently fulfill the necessities from the Restrictions on Medical Devices and IVDs.
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Progress and acceptance of medical devices, publish-advertising and marketing surveillance
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I'm an FDA regulatory pro witness and an FDA compliance marketing consultant skilled within the laws and submissions of medicines, biologics and medical devices.
They understand how to harmony the reward-chance ratio Together with the practicalities of regulatory compliance. Mainly because NAMSA performs preclinical scientific tests, medical exploration and screening on 1000s of medical devices and IVDs yearly, our consultants arrive at Every single task by using a properly-knowledgeable feeling of what the US FDA, European Notified Bodies as well as other regulators anticipate to determine.
We would be the Expert contact for all thoughts that crop up regarding industry necessities, medical devices directives and particularly The brand new EU polices on medical devices.