The Clinical Evaluation Consultation Procedure (CECP) is an extra requirement of a clinical evaluation process under 745/2017 MDR for implantable Class III
EUDAMED is MDR’s one of the most critical aspects as it's intended to act as a “living database” of every medical device that is roaming the European Union.
The Person Responsible for Regulatory Compliance (PRRC) is a position that was introduced with the MDR and should not be confused with quality assurance managers
MDR’S sole goal and purpose are to update the EU rules regarding the safety and performance of medical devices to ensure that patients get the best possible technology with the absolute minimum risk
Guidance documents, just like international standards are non-binding but useful tools to help the relevant parties interpret the regulation.
In cases where the use of sutures is required, surgical knotting as part of traditional methods is usually utilized, hence the use…
Anterior cruciate ligament (ACL) injuries are common. It is frequently encountered in various sports branches such as football, basketball, and gymnastics.
Sterilization is a process that aims to destroy and remove all-living microorganisms, and
viable spores from an object.
The success of the procedure performed in surgical operations and the good result achieved
The clean room is designed to protect products, tools, people and equipment from particles such as particles…