CARAQA

Certified Course of Advanced Studies designed to prepare Regulatory, Clinical, and Quality experts in the MedTech industry.  

Our program offers a unique blend of theoretical knowledge and hands-on practice, enabling professionals to navigate complex EU and US regulatory landscapes.  

Delivered by state-accredited engineering schools, CARAQA is an on-the-job training that not only meets the competence requirements of the MedTech industry but also helps manufacturers and authorized representatives fulfil the EU Article 15 obligations by identifying a person responsible for regulatory compliance (PRRC).  
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Certified Training Program
Delivered by state-accredited engineering schools
 
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Multiple Locations
Classes available in Switzerland and Belgium
 
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Person Responsible for Regulatory Compliance

Supports compliance with the EU Article 15 by identifying a PRRC
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The Program

Our goal is to cultivate adaptable leaders who can drive organizational strategy, maintain competitive edge, and ensure sustainable growth in the complex MedTech ecosystem. In response to the rapidly evolving Clinical Affairs, Regulatory Affairs, and Quality Assurance (CA/RA/QA) functions, the CARAQA program is meticulously designed to empower professionals with a comprehensive skill set that transcends technical expertise: 

  • Optimal preparation for MDR 2017/745 and IVDR 2017/746 regulatory transitions 

  • Strategic planning and management of clinical evaluations, investigations, and performance studies under ISO 14155 and IVD standards 

  • Advanced communication strategies for effective interaction with Notified Bodies and National Competent Authorities, including crisis management skills 

  • Management and engineering support throughout new product development projects 

  • Leadership in the deployment and maintenance of Quality Management Systems aligned with ISO 13485 and US QSR requirements 

  • Strategic structuring of supply chain, production and marketing processes 

  • Technical expertise in critical domains such as risk management, biocompatibility, usability, and software validation, ensuring compliance with current standards 

Duration 

Average of 200 hours over 6 months 

Classes 

Classes are held once or twice per week in loco for the entire day 

Exam 

An exam covering the whole program is planned at the end 

Thesis 

Participants will write and present an individual thesis on a pre-approved subject 

Diploma 

A diploma will be handed in a formal ceremony as a sign of program completion 

Structure
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Target Audience

The program is strategically designed for MedTech professionals navigating the complex landscape of Clinical, Regulatory, and Quality Affairs across medical device and in-vitro medical device industries:

  • Regulatory, clinical, and quality assurance department professionals seeking to enhance their strategic capabilities

  • Engineers in electronics, mechanical or software disciplines, in charge of medical device or in-vitro medical device projects

  • Manufacturing and production experts looking to deepen their regulatory and quality understanding

  • Physicians, scientists and inventors developing innovative medical products

  • Laboratory professionals involved in developing new analytical methods or process automation

  • Healthcare organization employees engaged in clinical studies or quality/regulatory processes

Admission Criteria
Formal entry qualifications:
  • A tertiary educational qualification (minimum Bachelor’s level) with relevant work experience
  • or a Diploma HF (from a Swiss “Höhere Fachschule”) with relevant work experience
Specific admissions if the applicant does not qualify as per formal criteria above:
  • At least 3 years’ work experience corresponding to or related to the relevant Continuing Education Program.
Additional prerequisites:
  • Proficiency in English (reading and writing), as all instruction and educational materials are delivered in English
  • Program coordination by Veranex Switzerland SA

Choose your CARAQA

CARAQA programs are currently available in two of the most dynamic European medtech markets: Switzerland and Belgium. Secure your place in the next session:

Testimonials

BG-1

“The whole course has been extremely well structured, interesting and well taught.Every speaker was inspiring, full of knowledge and experience. I enjoyed the trainers’ personal comments about their experiences in the industry in relation with the training’s content. The presentations included good pratical case studies.

It was for me an optimal preparation to face the new challenges of the upcoming IVDR.

I highly recommend this training to anyone having to navigate and comply with the medical devices regulations and approval processes.”

Tiphaine Descombes

CARAQA Alumna 2020 - QA/RA Manager, 1DROP

BG-2

“Taking part to the CAS-CARAQA program helped me dive deep in the complex MedTech regulatory field and gain confidence as a RAQA professional.

The program, well designed to address a wide audience from medical devices and in-vitro diagnostic companies, superbly integrates diverse learning tools, from class lecture to hands-on sessions and talks from regulatory and Industry experts, with case scenarios shaped to reflect both start-ups and corporate realities. The great mosaic of notions is finely balanced with sharing of professional experiences and real-life cases by the highly skilled trainers.

I am absolutely enthusiastic about this program and recommend it to both aspiring and experienced CA/RA/QA professionals, as well as to CEOs.”

Valentina Lintas

CARAQA Alumna 2020 - Regulatory Affairs and R&D, LifeMatrix

BG-3

“That was a pleasure participating in the CARAQA program. We came from different angles of the industry with different experiences and gained a common solid knowledge about the recent changes in the Medical Device, In vitro Diagnostics Industry. The program is built up with clusters, the clusters are linked, cross referenced, so we have got familiar with this complex system in a practical manner through case studies and challenging discussions. I am happy and also proud that I completed the CARAQA.”

Zsuzsanna Tokai

CARAQA Alumna 2020 Senior Global Regulatory Manager

Book your 15' call

To discover how CARAQA can transform your professional journey to Medtech expertise,

book your 15-minute call with Zuzana Robin, your dedicated training coordinator.

Schedule a Call Today

Meet the CARAQA Managing Team

The CARAQA team brings together a powerful consortium of distinguished educators and industry experts, including professors from HEIG-VD in Yverdon-Les-Bains, the School of Life Sciences FHNW in Basel-Muttenz, UCLouvain in Louvain-La-Neuve, complemented by the extensive industry insights of Dr. Elena Lucano and Zuzana Robin from Veranex Switzerland SA.
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Prof Didier Maillefer

School of Management and Engineering, HEIG-VD

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Prof David Hradetzky

School of Life Sciences FHNW

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Prof Renaud Ronsse

UCLouvain

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Dr Elena Lucano

Training Manager, Veranex Switzerland SA

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