The European Union and MDSAP: A New Opportunity for Medical Device Certification
The Medical Device Single Audit Program (MDSAP) is one of [...]
New Notified Bodies for MDR & IVDR: CNCps and NSAI strengthen EU Certification
The European certification system continues to expand with the recent [...]
New EMA Procedure: Scientific Advice for High-Risk Medical Devices
The European Medicines Agency (EMA) has introduced a significant [...]
MDCG 2023-3 Rev. 2: Everything you need to know about the new vigilance rules
Important updates for manufacturers and importers: here’s what’s changing! [...]
Australia: New opportunities for medical device and IVD manufacturers
The Therapeutic Goods Administration (TGA) continues to modernize Australia's regulatory [...]
MHRA updates Post-Market Surveillance: How to adapt your medical devices to new requirements
The Medicines and Healthcare products Regulatory Agency (MHRA) has [...]
How to Ensure the Safety of Mobility Devices with Lithium Batteries: MHRA Recommendations
Lithium batteries are a critical technology for powering mobility devices [...]
Amendment to the Swiss Ordinance on In Vitro Diagnostic Medical Devices (IvDO) and the Medical Devices Ordinance: Update 2025
As of January 1, 2025, the amended Swiss Ordinance on [...]
EUDAMED Registration – A Comprehensive Guide for Manufacturers
EUDAMED Registration: Your Step-by-Step Guide Compliance with European regulations is [...]
Team-NB Guide December 2024: Your Complete Resource for Medical Device Certification
On December 18th, 2024, Team-NB, the European Association of [...]
