Clinical, Regulatory and Quality Affairs for Medical Devices and In-Vitro Diagnostics
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.
Supported by
The pandemic situation in 2020 is a challenge for people, organizations and industries around the world. To prevent shortages or delays in getting key medical equipment onto the European market, the EU have postponed application of the Medical Devices Regulation until May 26th, 2021. For Swiss medical device manufacturers this decision comes with extension of direct access to the European market, postponing EU “third country” status for a year. Nevertheless, the lack of an update for the mutual recognition agreement, Swiss medical device manufacturers are still facing serious threats.
Therefore, being well prepared for the changes in the regulatory landscape remains vitally important for all manufacturers. Professionals playing major roles in quality, regulatory or clinical affairs need to be well prepared to face these challenges. To develop and enhance this knowledge and combine it with hands-on experience, the School of Life Sciences FHNW and Medidee® offer a unique training opportunity: the Certificate of Advanced Studies in Clinical, Regulatory and Quality Affairs for Medical Devices and In-Vitro Diagnostics (CAS CARAQA), supported by Swiss Medtech. Experienced professionals from medical and in-vitro medical device manufacturers will share their insights and experience. They will empower participants with advanced knowledge and provide them with a broad range of skills to take duty as a person responsible for regulatory compliance (PRRC) according Art. 15 MDR and IVDR within their company.
The CAS CARAQA ‘21 will start in January. The performance of the CAS CARAQA 2021 is confirmed.
Content
The adoption of new European regulations on medical devices and in-vitro diagnostics has triggered major changes in the Medtech sector, resulting in pressure on employees in Clinical Affairs, Regulatory Affairs and Quality Assurance – CA/RA/QA.
Countries in the Gulf, Asia and South America now have requirements that are as complex as those in Europe or the USA. Exporting to these countries is therefore a challenge for Swiss firms.
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
Introduction to the world of devices
Understanding the MedTech environment
Getting to grips with product life cycle
Positioning and interacting with the entities involved
Course 1: Regulatory affairs, design and submissions
Structuring and implementing risk management
Integrating regulatory requirements during design
Managing implementation of directives, standards and recommendations
Maintaining regulatory conformity during product life cycle
Preparing the company for audits
Course 2: Quality Management
Structuring the Quality Management System deployment
Organizing documentation and its evolution
Supervising process control
Managing critical quality processes such as audit, improvement, changes
Course 3: Clinical Affairs
Structuring and organizing clinical / performance evaluations
Organizing a clinical investigation
Performing a literature review
Managing post-marketing studies
Overview
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
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.
CAS FHNW in Clinical, Regulatory and Quality Affairs for Medical Devices and In-Vitro Diagnostics
All three courses are subject to a final written exam and the writing and presentation of an individual thesis. The subject of the thesis is a complete CA/RA/QA study of a medical device or IVD device as per the guidelines laid down in the program. The device can be individually selected by each participant and may be linked to his/her professional activity.
A personal coach will be assigned to each participant, responsibility for supporting and supervising the CAS thesis. The thesis is written in English.
The program will take place at the School of Life Sciences FHNW, Campus Muttenz.
Every Tuesday (except Easter)
Final exam: July 20th 2021
Submission of final thesis: July 31st 2021
Defense: September 14/15th 2021
Medidee is a consulting firm specialised in Regulatory, Clinical affairs and Quality for medical devices and IVD. Medidee supports manufacturers, public organisations and health professionals facing the complex topics of compliance with legal requirements associated with the development, manufacture, validation and commercialisation of a wide range of technologies in the MedTech and BioTech fields.
Products include medical devices, active implants, IVD, standalone & embedded software and standardised transplants. Support often starts as early as the ideation and innovation phase, hence the company keeps in close contact with academic and start-up ecosystems and interaction with suppliers during the industrialisation phase is often key. At later stages, Medidee acts as CRO to strategise, design and obtain the approval of clinical investigations and to support the execution. Another important area of activity is the development and ISO 13485 certification / 21 CFR 820 compliance of quality management systems to ensure that the product is developed and manufactured correctly. Medidee has offices in Switzerland, Germany, Belgium, Denmark and the USA.
