This article focuses on the FDA approval process for medical devices, providing a step-by-step guide to accessing the US market.
This article helps you understand what an EU authorised representative is and what their general responsibilities are.
This article provides guidance on what documents MedTech manufacturers must include in their medical device technical files. The article also shares insights on how a medical device technical file is assessed for MDR compliance.
MedTech manufacturers can use the present guidance on medical device symbols to comply with the new, stricter MDR labelling requirements.
This post focuses on the medical device labelling requirements and user manual requirements under the EU MDR 2017/745.
This article presents three certification markings for energy-efficient products that manufacturers placing goods on the US market should consider.
Clever Compliance is investing in new digital tools that can help firms easily procure product certification services and streamline their compliance work.
FCC certification is a type of product certification for electronic and electrical goods that are manufactured or sold in the United States. Read here all that you need to know about it.
Some often-required types of product certification are CE marking, FDA, FCC and CB Scheme. You can read about each one of these types of product certification here.