Introduzione

The State of the Art section is not a new requirement under the EU MDR 2017/745.
However, the provisions for this section have been enforced, and it has become the fundament of the Clinical Evaluation Report.

The State of the Art section needs to identify benchmark devices besides information about the medical background, clinical conditions, and alternative therapies related to a medical device. Data about these benchmark devices are relevant to define safety and performance parameters and acceptance criteria. These criteria compare the subject medical device to the current State of the Art.

This requires a thoroughly structured systematic literature search and a deep understanding of the medical conditions related to the subject device.
Understanding the relevant parts of a State of the Art section and knowing where to start can be challenging.

Also, as a medical device professional, you may face devices with little background information for which the literature search can become challenging.

This workshop will give you profound insights into the State of the art's regulatory requirements, best practice recommendations on how to structure your search, and how to identify your benchmark devices and parameters.

  • Brief introduction: Regulatory framework; content and structure
  • Benchmark devices and benchmark parameters for safety and performance
  • Tricky case studies and how to deal with them: novel devices; devices with no published data; artificial-intelligence-based devices; software medical devices; and so on…
    • Systematic literature searches for the State of the Art
    • How to compare the State of the Art information to the subject device
    • Review cycles and updates
  • Can Language Automation Models (artificial intelligence [AI]) help us draft the State of the Art?

This course is intended for medical device professionals who already have some experience in writing Clinical Evaluation Reports, including State of the Art Sections, under the Medical Devices Regulation 2017/745 (MDR) and are looking for advanced training.

Participant experience
We will assume that participants have a good knowledge of the directives and regulations governing medical devices, such as the MDR.

The lecturer will deliver short presentations on the program topics. Questions and subsequent discussions are welcome at any time during the workshop.

A series of polling questions will illustrate participants’ ideas and perceptions on the topics presented.
In breakout rooms, small groups of participants will have the chance to work on exercises related to the State of the Art section.

Docente/i
Laura C Collada Ali
Info

Laura C Collada Ali

Senior Medical Writer & Scientific Manager, LS Academy
Laura is a medical writing consultant with more than 22 years of experience in delivering multilingual authoring services for leading pharmaceutical and medical device companies. She regularly prepares content for lay audiences to be used in patients’ brochures, patients’ information sheets and consent forms, summaries of safety and clinical performance (SSCPs), and web content both for pharma and medical devices in the fields of oncology, orthopaedics, cardiology, dermatology, and infectious diseases among others. She’s an active member of the European Medical Writers Organization (EMWA), where she serves as Educational Officer and member of the Executive Committee.

Online Training – 2 modules

MODULE 1 | 01 October 2024  9:00 am to 11:30 am CEST
MODULE 2 | 02 October 2024  9:00 am to 11:30 am CEST

Some days before the online training you will receive all details about the connection.

The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.

Early Bird: € 510,00* (until 17 September 2024)

Ordinary: € 645,00*

Freelance – Academy – Public Administration**: € 380,00*

* for Italian companies: +22% VAT

** Early Bird discount not applicable to Freelance – Academy – Public Administration fee

The fee includes: tuitions, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.

Registrati
Early bird
Acquistabile fino al 17/09/2024
€510,00
Ordinaria
Acquistabile fino al 30/09/2024
€645,00
Freelance - Accademia - Pubblica Amministrazione
Acquistabile fino al 30/09/2024
€380,00
Svuota
Versione Stampabile
Cosa saprai fare dopo il corso
Risultato atteso
Know the requirements for the State of the Art section under EU MDR 2017/745
Risultato atteso
Structure a systematic literature search for relevant background information
Risultato atteso
Identify benchmark devices and safety and performance parameters
Risultato atteso
Know how to structure the information for your State of the Art section
<p><span>Online interactive training on Zoom platform. </span></p> <p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>

Online interactive training on Zoom platform. 

LS Academy will provide the access link to the virtual platform a few days before the training.

<p><span>Online interactive training on Zoom platform. </span></p> <p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>
Vedi tutte le edizioni
State of the Art Section for Medical Devices Inside-Out