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In this white paper, we discuss how to determine if your wearable product is considered a regulated medical device by the US FDA.
US FDA 510(k)s have unique content and format requirements. Get an overview of preparing and submitting a 510(k).
Learn about the Unique Device Identification (UDI) regulation, how to obtain a UDI number, compliance deadlines, and more.
Correct classification of a medical device is critical for identifying its proper regulatory route in the United States.
In this paper, we answer your biggest questions about the obstacles and opportunities of marketing companion diagnostics in the US and Europe.
In a 510(k) submission, what testing is required by the FDA to clear the device? While testing requirements are easy to determine for some devices, other devices require intensive research.
Are you ready to launch your mobile medical app in the United States? Depending on the functionality of your app, you might need clearance from the US FDA.
When preparing a 510(k) submission for a device labeled as sterile, you should carefully consider which sterilization method to use because it will affect the FDA’s expectation.
In this white paper, we discuss US regulations for wireless medical devices, including submission requirements, risk management, and more.
Does your medical device contain animal or human cells or tissues? Learn about FDA requirements for these products.
Learn about substantial equivalence, which is the key to getting your Class II medical device cleared for sale by the US FDA.
This white paper provides a high-level overview of the US FDA 21 CFR Part 820 and the implementation process, including timelines and strategies.
Discover guidelines, tips, and other useful information about corresponding with the FDA about the clearance of your medical device.
This whitepaper discusses how to bring a novel device to the US market, including common pathways, exemptions, and the de novo process.
Learn about usability engineering studies, including FDA requirements, standards, and how to conduct a usability study.
This paper describes exactly what to expect from a random FDA audit and how to prepare for the inspector's arrival in a concise checklist.
Post-market surveillance is a regulatory requirement the US and Europe and helps you ensure your device's safety and effectiveness.
If you are marketing a device in Europe, the US, or even beyond, the ISO 10993 series is your guide to biocompatibility testing requirements.
This white paper discusses potential strategies for achieving global market compliance for your device.
In this white paper, we discuss the steps you should follow to achieve MDSAP certification.
This white paper US quality assurance requirements for human clinical studies and breaks down the key elements compliant study.
This white paper addresses Purchasing Controls, one of the biggest QSR compliance vulnerabilities for medical device companies selling in the US.
ISO 11135:2014 is recognized as the international standard for process management and validation requirements of Ethylene Oxide (EO) sterilization.
Regulatory expectations for risk management are increasing - what does this mean for medical device companies?