2021-03-26
FDA Approval Process for Medical Devices: Step-by-Step Guide
This article focuses on the FDA approval process for medical devices, providing a step-by-step guide to accessing the US market.
2021-03-03
Responsibilities and Mandate of an EU Authorised Representative
This article helps you understand what an EU authorised representative is and what their general responsibilities are.
2021-03-02
Medical Device Technical File for MDR Compliance
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.
2021-02-16
10 Medical Device Symbols You Must Know About
MedTech manufacturers can use the present guidance on medical device symbols to comply with the new, stricter MDR labelling requirements.
2021-02-11
EU MDR Labelling Requirements for Medical Devices
This post focuses on the medical device labelling requirements and user manual requirements under the EU MDR 2017/745.
2021-02-09
3 Certification Markings for Energy-Efficient Products US Manufacturers Must Consider
This article presents three certification markings for energy-efficient products that manufacturers placing goods on the US market should consider.
2020-02-21
Clever Compliance, A Revolution in Product Certification
Clever Compliance is investing in new digital tools that can help firms easily procure product certification services and streamline their compliance work.
2020-02-04
Do I Need FCC Certification?
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.
2020-01-31
4 Types of Product Certification Often Required and Recognised Worldwide
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.