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…
Read articleRefuse 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…
Read articleCommon 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) &…
Read articleQuality — 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…
Read articleHow 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…
Read articleAll 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…
Read articleA 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…
Read articleEU 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…
Read articleIs 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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