CE Marking – An important requirement for the European Market
A CE Marking is a much sought-after symbol, as it allows companies to gain access to the large European market. CE Marking…
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Refuse to Accept – An important milestone for your device during the FDA review process
Why RTA? The FDA conducts an acceptance review of a 510(k) submission (Traditional 510(k), Abbreviated 510(k), or Special 510(k)) against acceptance criteria…
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Common pitfalls during the CE marking of a Medical Device or IVD
A CE (Conformitè Europenne) Mark is mandatory for medical devices manufactured, designed, marketed, and supplied within the European Economic Area (EEA) &…
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Quality — The key to customer satisfaction
Quality in a service or a product is not what you put into it; it’s what the end user gets out of…
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How do IVDs differ from LDTs? Confused? Here’s the key
Diagnostic laboratories in today’s world face a slew of issues; from managing complicated test panels to handling ever-increasing sample quantities. In order…
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All you need to know about a Premarket Approval (PMA) Submission — Route to the US Market for Class III medical devices
The Federal Food Drug and Cosmetic (FD&C) Act established three regulatory classes for medical devices – Class I, Class II, and Class…
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A to Z of a Clinical Evaluation Report
One of the most integral parts of getting regulatory approval in the European Union (EU) is a Clinical Evaluation Report (CER) that…
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EU Classifications and Rules for CE Marking
For the manufacturers trying to figure out ways to place their medical devices in the EU market, classifying their devices based on…
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Is your product Misbranded?
Misbranding is a serious issue in the healthcare industry. For all the claims, indications for use, and other labeling details accompanying the…
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