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 offers the industry's most extensive training courses, including customised training programmes to be performed on-site oronline, for all types of organisations, from large to small. Courses are delivered by specialists possessing considerable first-hand experience in each topic, who can respond to questions and real-life situations knowledgeably.
Our bespoke courses are customised around your needs and allow you to meet the specific requirements of your business.
European and UK medical device regulations & standards compliance and application
Biological safety assessment according to EN ISO 10993-1
Clinical evaluation, including identification, analysis, assessment and evaluation of empirical and published data; post-market clinical follow-up
QFI'S CORE COURSES
We offer training and education in compliance with medical device regulations and standards, including EU, UK and US regulations, MDSAP and Data protection in the following areas:
PRINCIPLES AND PRACTICE OF REMEDIAL ACTION COURSE
Full course documentation is provided. Certificates of attendance, completion of achievement, etc are offered.
On-site or online
One-day seminar is designated to examine the origin of action demanded by EN ISO 9000 and EN ISO 13485, concentrating on corrective and preventive action (CAPA), and explore the correlation between the standards. Attending the seminar will help the company in satisfying its customer's safety, meet regulatory requirements, and achieve continual improvement. It should be considered to be a first step or the base level of a quality system effective solution to meet the comprehensive requirements for a Quality Management System (QMS).
Is this course right for you?
The course is designated for individuals with an understanding of quality management systems’ concepts, including GMP, quality managers, regulatory affairs managers, consultants, anyone involved in the regulatory, quality and technical functions.
Attendees will learn to:
⁘ differentiate action;
⁘ analyse episodes of non-conformity and resulting action;
⁘ devise solutions; and
⁘ plan and manage efficiently.
This course concentrates on elements applying to products placed on the market with the CE mark according to various European Directives on medical devices. Where appropriate, attention is devoted to US expectations.