CE-Certificate vs. EC-Certificate
Basic UDI-DI (bUDI) - what is it, where to obtain it, and what to do with it
EUDAMED registration - a brief guide
Contract with the Authorised Representative in the European Union (Authorised Representative Mandate)
GSPR – General Safety and Performance Requirements for medical devices in the European Union
How to obtain CE marking for medical software under the EU MDR or IVDR?
Technical documentation for Medical Device Software in the EU
IEC 62304 - the pivotal standard for software medical devices
Medical Device Regulation (MDR) - basics
ISO and IEC standards for medical device software
Clinical Evaluation, PMCF, and PMS in Medical Device Lifecycle
Notified Bodies and their role in certification of medical devices
What is NANDO and why medical device companies should know about it?
Labeling and UDI requirements for medical devices in the EU
Understanding the roles of Authorised Representatives and Importers under MDR/IVDR
MDR implementation - challenges and solutions
Post-market surveillance under MDR and IVDR - requirements and best practices
Notified Body audit - a manufacturer's guide
Risk management plan - guide for medical device companies
Should my medical device comply with GDPR?
EC-certificate for a medical device - Q&A
How long does it take to CE-mark a medical device?
What is a PRRC?
Essential requirements for importers and distributors under MDR and IVDR
Language requirements for IFUs and labels under the MDR and IVDR
Legal Manufacturer and Original Equipment Manufacturer in medical devices
How to structure a PRRC contract for effective compliance
How to Create a Declaration of Conformity According to MDR or IVDR
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