Frequently Asked Questions
Answers to common questions about medical device and IVD regulatory compliance consulting.
What is medical device regulatory compliance consulting?
Medical device regulatory compliance consulting helps manufacturers meet the legal and quality requirements needed to design, test, and market medical devices in a given country or region, covering areas such as documentation, quality management systems, and regulatory submissions.
What is an In Vitro Diagnostic (IVD) device?
An IVD device is a medical device used to examine specimens such as blood or tissue outside the body to diagnose disease, monitor health, or guide treatment decisions. IVDs are regulated separately from other medical devices in most jurisdictions.
What is Software as a Medical Device (SaMD)?
SaMD refers to software intended for one or more medical purposes that performs these purposes without being part of a hardware medical device. It is regulated based on its intended use and the risk it poses to patients.
What is post-market surveillance for medical devices?
Post-market surveillance is the ongoing monitoring of a medical device's safety and performance after it has been released to the market, including complaint handling, adverse event reporting, and vigilance reporting to regulatory authorities.
Which regulatory agencies does MedoQi support?
MedoQi's team has provided regulatory support across a wide range of global regulatory agencies covering medical devices and IVDs, helping clients navigate submissions and compliance requirements in multiple jurisdictions.
How do I get started with MedoQi?
You can request a demo or reach out to MedoQi's team directly through the "Request For Demo" option on this site, or by contacting one of MedoQi's global offices listed in the Contact Us section below.