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CARAQA - Clinical, Regulatory and Quality Affairs for Medical Devices and In-Vitro Diagnostics

CAS

Fachhochschule Nordwestschweiz FHNW > Hochschule für Life Sciences

Ajouté à myOrientation

Catégories
Lieu de formation

Muttenz (BL)

Langue d'enseignement

anglais

Type de formation

Hautes écoles spécialisées HES - Formation continue: formations longues

Modalités temporelles

À temps partiel

Thèmes de formation

Chimie, matières synthétiques, papier - Électronique, microtechnique - Santé, soins, médecine

Domaines d'études

Chimie - Sciences biomédicales et technologie - Sciences pharmaceutiques - Technique médicale

Swissdoc

7.724.9.0 - 7.540.11.0 - 7.555.33.0

Mise à jour 11.03.2021

Description

Description de la formation

CAS: Certificate of Advanced Studies (CAS) ist eine Nachdiplomausbildung der Hochschulen und entspricht mindestens 10 ECTS.

Faced with the evolution of CA/RA/QA functions, the aim is to develop a broad range of technical and human skills in order to evolve towards the organisation’s decision-making centres and play a key role in maintaining the company’s competitiveness and sustainability.

The CAS CARAQA develops the following skills:

  • Optimal preparation for MDR 2017/745 and IVDR 2017/746 regulatory changes
  • Strategic planning and management of clinical evaluations, investigations under ISO 14155 and IVD performance studies
  • Strategic and tactical communication for interaction with Notified Bodies and National Competent Authorities and to deal with crisis situations
  • Management and engineering support during new product development projects
  • Leadership in the deployment and maintenance of Quality Management Systems under ISO 13485 and US QSR
  • Structuring of supply chain, production and marketing structuring
  • Technical expertise in key subjects such as risk management, biocompatibility, usability, and software validation, according to current standards

Plan de la formation

13 ECTS-Punkte

1 ECTS-Kreditpunkt entspricht einem Arbeitsaufwand von 25 bis 30 Arbeitsstunden.

Program Structure

  • Introduction to the world of devices
  • Course 1: Regulatory affairs, design and submissions
  • Course 2: Quality Management
  • Course 3: Clinical Affairs

Admission

Conditions d’admission

Formal entry qualifications:

  • Tertiary Educational Qualification (at least Bachelor’s level) and relevant work experience
  • or Diploma HF (from a Swiss “Höhere Fachschule”) and relevant work experience As the instruction and educational materials are in English, proficiency in English (reading and writing) is a prerequisite.

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.

 

Zielgruppe

The program is aimed at people in medical device and in-vitro medical device companies (as well as subcontractors) who are facing direct or indirect challenges in a CA/RA/QA environment.

  • Employees in the regulatory, clinical and / or quality assurance department
  • Engineers from electronics, mechanical or software disciplines, in charge of medical device or in-vitro medical device projects
  • Experts in manufacturing and production
  • Physicians, scientists or inventors of medical products
  • Laboratory assistants involved in the development of new analytical methods or process automation
  • Employees involved in clinical studies or quality/regulatory processes in a healthcare organization

Inscription

Final application date: Nov 03, 2019

Coûts

CHF 8'800.-

Diplôme

  • Certificate of Advanced Studies CAS

CAS FHNW in Clinical, Regulatory and Quality Affairs for Medical Devices and In-Vitro Diagnostics

Infos pratiques

Lieu / adresse

  • Muttenz (BL)

Déroulement temporel

Début des cours

Januar 2022

Durée de la formation

26 days over 6 months
Tuesday

Modalités temporelles

  • À temps partiel

Langue d’enseignement

  • anglais

Remarques

In collaboration with Medidee, the School of Life Sciences FHNW offers a unique training opportunity for Medtech professionals facing the current major regulatory challenges. The CAS-Program fulfils the requirements of article 15 of MDR / IVDR.

Liens

orientation.ch