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.
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.
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.
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.
Compliance Program: Definition & Elements
This article provides clarity on what a compliance program is and what elements it consists of.
Main Challenges in Ensuring Product Safety
Read this article to learn about the main challenges in ensuring product safety.
Product Labelling Requirements for Europe
Read this guide to learn about the mandatory and voluntary product certification markings for goods placed on the European market.
10-Step Guide to Meeting SCIP Requirements
Check this step-by-step guide to learn how to meet SCIP requirements, and learn if the SCIP regulation actually applies to you.
Information Requirements for SCIP Notifications
Duty holders must consider three types of information requirements for SCIP notifications: mandatory, required and optional. Learn more here.
6 Tips for Successfully Managing Supplier Compliance
Poor supplier compliance management can result in unforeseen compliance issues. Here are 6 tips to help you improve your supplier compliance.
