Choosing the right laboratory for surgical implant testing

Biomechanical validation of a surgical implant is a critical step prior to commercialization. Not only patient safety depends on it, but also the regulatory feasibility and market success of the product. However, choosing the right laboratory to perform testing is not always straightforward. Not all centers have sufficient accreditations, technology or experience to meet the […]

What is ISO/IEC 17025 accreditation and why is it key in medical device testing?

In a sector as regulated as the medical device industry, the reliability of test results is an indispensable requirement. ISO/IEC 17025 accreditation has become the international standard that guarantees the technical competence of laboratories and the validity of their measurements, two essential aspects to comply with the European Medical Device Regulation (MDR 2017/745) and obtain […]