Hip replacement trials: what does MDR require?
Hip prostheses are one of the most widely used implants in modern orthopedic surgery. Their development combines advanced engineering, high-performance biomaterials and rigorous biomechanical validation.With the entry into force of the European Medical Device Regulation (MDR 2017/745), testing and technical documentation requirements have become more stringent, seeking to ensure greater safety, traceability and clinical evidence. […]
Bone plate assays: from trauma surgery to the laboratory
In traumatologic and maxillofacial surgery, bone plates -also known as osteosynthesis plates– are essential elements for stabilizing fractures, enabling bone healing and restoring skeletal function.Their reliability depends on their mechanical strength, structural rigidity and durability under actual loading conditions. To ensure these factors, manufacturers must perform biomechanical and regulatory tests to validate the performance of […]
MDR 2017/745 explained: key issues for medical device manufacturers
Regulation (EU) 2017/745, known as MDR (Medical Device Regulation), has completely transformed the regulatory landscape for medical devices in Europe. This regulatory framework replaces the old directives (MDD 93/42/EEC and AIMDDD 90/385/EEC), imposing stricter requirements to ensure safety, traceability and transparency throughout the medical device lifecycle. For manufacturers, understanding and correctly applying the MDR is […]
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 […]
