ONGOING PROFESSIONAL DEVELOPMENT
TRAINING AND COURSES
We recognise clients should ensure their employees receive appropriate education and training to fulfil requirements of an ever-changing global medical device regulatory domain and be able to demonstrate both competencies and competence.
QFI has developed over 100 training course, including customised training programmes to fulfil client needs and requirements. Courses are delivered by specialists possessing considerable first-hand experience in each topic, therefore, can respond to questions and real-life situations knowledgeably.
QFI’s CORE COURSES
We offer training and education in compliance with medical device regulations and standards, including Council Directive 93/42/EEC, 90/385/EEC and 98/79/EC | Regulation (EU) 2017/745 and /746, 21 CFR 820, MDSAP and Data protection in just some of the following areas:
- European medical device regulations & standards compliance and application
- Clinical evaluation, including identification, analysis, assessment and evaluation of empirical and published data; post-market clinical follow-up (according to MEDDEV 2.7/1 and PRISM)
- Medical device risk analysis (including EN ISO 14971 training courses)
- Medical device single-audit programme (MDSAP)
- Internal audit
- Medical device file according to EN ISO 13485
- Corrective and preventive action
- Biological safety assessment according to EN ISO 10993-1
Certain courses can be offered leading to diplomas.