Finding the art in medical device compliance Notified Bodies need to evaluate the medical device´s operating risk-benefit ratio and various other factors and, in order for them to do so, the MDR 2017/745 and the MEDDEV 2.7.1 (Rev 4) states that they require a description of the “state of the art” in the medical field associated with […]

Crafting an Effective Clinical Evaluation Plan The MEDDEV 2.7.1 (Rev 4) introduced the requirement of a Clinical Evaluation Plan (CEP) and the Medical Device Regulation (MDR 2017/745) gave more details on what this new and critical document should contain (particularly in Annex XIV, Part A). The scope of the full clinical evaluation is stated in the CEP and includes, at the very […]

Writing a Successful Clinical Evaluation Report As medical device companies work toward complying with the more stringent medical device regulations and guidelines, the role of effective medical writing becomes increasingly important. Central to being compliant with the new Clinical Evaluation requirements is the development of novel documents, including the Clinical Evaluation Report (CER). The fourth […]

You have options! Your study may not need a full CSR for your marketing application. Depending on the type of study you are conducting, or its intended purpose, it may only be necessary to submit an abbreviated version of the full ICH E3 CSR. The FDA and EMA have produced a series of guidelines and legislation aimed at clarifying […]

How you can save up to 70% of time spent on Medical Review of Patient Eligibility Medical review of patient eligibility is one of the important tasks of the Medical Monitor (MM) that might consume significant part of his time, especially in large global studies. Traditionally, in eligibility review, individual patient data is reviewed either directly in […]

  Since its launch few months ago, several industry professionals (Medical, Operational and Technical) have participated in PenThu® Simulator Program. We really appreciate the excellent feedback received from all users who took the opportunity to try-out the first Interactive Guidance Management System “IGMS” in the clinical research industry. The Simulator Program is a free service. Team members […]