New Medical Device Evaluation

European medical device regulation: a new era?

By the spring of 2005, the European Commission hopes to present the first draft of the revisions to the Medical Device Directive to the European Council and Parliament. However, these revisions represent only part of the changing European regulatory scenario. This article discusses a tangible shift in European medical device regulatory policy and some actions that companies can take to understa...

Technical evaluation of a new sterile medical device to improve anticancer chemotherapy administration.

PURPOSE/OBJECTIVES To assess the PCHIMX-1 (Doran International), a new sterile medical device intended by its manufacturer to improve the quality and safety of cytotoxic drug infusions, as well as its influence on manipulation times required for pharmacy technicians and nurses and its effect on infusion line outflow parameters. DESIGN PCHIMX-1 assemblies were compared to standard infusion set...

A New Stethoscope Design with Unique Characteristics and Development in Medical Device

As regards the significant role of stethoscopes in the diagnosis of congenital and adventitious heart diseases and prevention of irreparable complications of these diseases, the quality of hearing sound of these stethoscopes by a physician has a significant impact on the disease diagnosis. This device plays an important role in the early diagnosis of congenital heart and respiratory diseases an...

A new approach to verifying and validating medical device development

A new geometric and mechanical verification device for medical LINACs

The goal of quality assurance (QA) for a radiation oncology medical LINAC is to maintain an acceptable level of equipment performance and reliability. The increasing complexity of Radiation Oncology equipment and treatment techniques have led to increased demands on the work load of the medical physicist. Regular testing needs to be as efficient as possible. Generally, the QA tests, as recommen...