BLOG
QMSR, Quality Management System Regulation. What changes for a manufacturer that exports to multiple markets
For years, comparing ISO 13485 with the U.S. Quality System Regulation meant maintaining two parallel frameworks: the international standard and
How to Prepare for the Validation of a Spinal Implant Prior to CE Marking
A spinal implant must maintain its function under conditions of repeated loads, complex geometries, and significant anatomical variability. For a
How to Validate Cervical Plates Without Relying on Cadaver Tests: The IBV Experience
The biomechanical validation of a cervical plate poses a significant challenge for manufacturers of medical devices intended for spinal surgery.
What requirements does the MDR impose on a manufacturer outside the European Union?
The European market remains one of the main destinations for manufacturers of medical devices from countries such as India, China,
What is critical load in dental implants?
In dental implantology, one of the most relevant concepts from the biomechanical point of view is the critical load. This
Differences between MDR and MDD for manufacturers
The move from Directive 93/42/EEC (MDD) to Regulation (EU) 2017/745 (MDR) has brought about one of the biggest regulatory changes
