Topic outline

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  Topic 1

  • Course introduction

    In cooperation with Swiss MedTech company Medidee and Technische Hochschule Lübeck, oncampus offers a unique training to face the major challenges of EU and International Regulatory Affairs in the field of medical devices.

    The CARAQA course is so unique because it offers an exciting mix of university training, information exchange with industry representatives and consulting services from an internationally leading consultant.

    Experts from the university sector and the MedTech company Medidee as well as regional and international industry representatives will share their insights and experience, will empower you with advanced knowledge and provide you with a broad range of skills to even take duty as a person responsible for regulatory compliance (PRRC) within your company.

    After completing the CARAQA training you will not only be able to perform a smooth transition to the requirements under the EU MDR/IVDR, but you will have insight in various aspects of international registration of medical devices including IVD medical devices. Of course, the training will also cover an in-depth discussion of implementation concepts for QMS and RMS requirements and most current regulatory perspectives on digital health. More information on the content can be found in the study plan of CARAQA Lübeck.

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  • CARAQA Online Info Event
    

    Gain further information about the high-level CARAQA training at our info event (free of charge).

    With Prof. Dr. Folker Spitzenberger (TH Lübeck)
    and Dr. Elena Lucano (Medidee)
    

    June 12th, 5:00 pm
    

    Register for Info Event
• Topic 2
  
  

  Topic 2

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  • CARAQA course data
    

    Course start:

    October 6th

    Registration deadline:

    September 6th

    Location:

    online training and 4 onsite sessions at TH Lübeck

    Cost:

    5.000 € including VAT

    Financial support:

    Weiterbildungsbonus Pro Schleswig-Holstein

    Discount:

    10 % for members of Life Science Nord

    Language:

    English

    Workload:

    154 hours
  • Questions
    

    Book your free individual CARAQA consultation session!
    
    

    With Dr. Elena Lucano: course content, suitability of the professional profile, CARAQA career options.

    Course information

    
    

• Topic 3
  
  

  Topic 3

  • Context: EU regulations

    The new European regulatory framework for medical devices (Regulation (EU) 2017/745 on medical devices - „MDR“ - and Regulation (EU) 2017/746 on in vitro diagnostic medical devices - „IVDR“) leads to numerous consequences for all stakeholders of the medical device sector.

    New requirements represent significant challenges, for example with regard to the implementation of a quality management system for medical device manufacturers regardless of the medical device risk class, demonstration of sound clinical evidence for the devices, implementation of the new UDI identification system etc.

    In this context, the „PRRC“, the „person responsible for regulatory compliance“ according to Article 15 of the MDR/IVDR is also newly introduced.

    This demanding context requires highly qualified and competent staff to meet and to resolve the current and future regulatory tasks.

    
    

    Training content: Clinical Affairs, Regulartory Affairs and Quality Assurance

    The CARAQA training is structured into three main pillars: Clinical Affairs, Regulatory Affairs and Quality Assurance – CA/RA/QA. It will qualify attendees to demonstrate the requisite expertise in the field of medical devices and IVD medical devices in order to fulfill the tasks and responsibilities of a PRRC according to Article 15, MDR/IVDR.

    Learners will be enabled to

    • Identify, analyse and resolve the major challenges of the regulatory changes due to the MDR and IVDR
    • Use strategic, tactical and communication skills when interacting with notified bodies and competent authorities
    • Develop technical expertise in key topics of conformity assessment such as quality management, risk management, post-market surveillance, biocompatibility, usability, safety, clinical investigation and evaluation, and software validation
    • Provide management and engineering support during the development and production of new biomedical products

    The Study Plan can be downloaded here.
    

    Schedule:
    Fridays: 8 hours à 45 min: 09.00 - 10.30, 11.00 - 12.30, 13.30 - 15.00, 15.30 - 17.00
    Saturdays: 6 hours: 09.00 - 10.30, 11.00 - 12.30, 13.30 - 15.00

    
    

    Target audience: MedTech professionals and beyond

    • Biomedical, mechanical, electronic, software or material science engineers, in charge of medical or IVD development and production projects
    • Physicians, pharmacists, scientists or inventors of biomedical devices
    • Employees within the regulatory, clinical and/or quality department of a manufacturing or subcontracting company manufacturing medical devices or IVD, or in a healthcare organization

    You are interested in the course but your profile does not match the information above? Don´t hesitate to apply and our experts will evaluate if CARAQA is the right fit for you.

    
    

    Organization: The „where, when and what“

    The CARAQA training will start on October 6th, 2023 and will end by its last course on March 8th, 2023. A final written examination will take place at the end of March (to be confirmed). 

    The training program includes: Lectures, demonstrations, practical exercises and extramural visits.

    The final exam consists of a written exam and a personal written report produced during the training modules and developing the regulatory, clinical, and quality pathways of a selected technology. This report will further be presented to the certificate jury at the end of the training.

    The course language is English.

    
    

    Registration: How can you attend?

    Registration Overview

    Applicants must fill in the online registration form and give information about their

    • educational background
    • experience
    • motivations for taking the certificate course.

    Applications will be reviewed by the program jury in order of submission.

    Conditions for Registration

    Candidates should have the following minimum qualifications:

    1. A Bachelor or Master’s degree from a University or equivalent, in:
    • Engineering: Biomedical, Mechanical, Electronic, Software, or Materials Science OR
    • Medicine, Pharmacy, Sciences, or Life Sciences OR
    • Management or Business Economics
    2. At least half a year of professional experience in regulatory affairs or in quality management systems relating to medical devices/medicinal products.

    If these requirements are not met, admission via a secondary education level is possible, if it can be demonstrated in a suitable educational domain (e.g. physical or chemical laboratory assistant) with extensive professional experience.

    As the instruction and educational materials are provided in English, proficiency in English (reading and writing) is a prerequisite.

    Registration Fee

    Registration costs are 5.000,- Euro including VAT.

    These fees include lectures, course materials, practical exercises, catering, access to the site and facilities and access to the online-courses and related tools.

    Discount: 10% for members of Life Science Nord

    REGISTER NOW

    
    

    University certificate

    Participants attending the programme and passing the exam will be awarded a “University Certificate in Clinical, regulatory and quality affairs for medical devices and in-vitro diagnostic medical devices”.

    In addition, this certificate can be used to obtain recognition as credit points related to modules of the online-Master study program „Master of Science Regulatory Affairs“ at the Technische Hochschule Lübeck.

    
    

    Lecturers

    The team of CARAQA lecturers is composed of experts from the university sector and Swiss MedTech Company Medidee, as well as regional and international industry representatives:

    

    
    Prof. Dr. Folker Spitzenberger,
    Technische Hochschule Lübeck
    
    

    
    

    

    
    Philippe Etter,
    Medidee Services SA
    
    

    
    

    And many other experts.

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    Your Contact

    

    Sabrina Reis
    +49 451 160818 62
    caraqa@oncampus.de

    Specific questions? Sabrina will have the answers.

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    Project partners:

    
    

    

    

    
    

    
    
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