2 Educators providing Courses in London

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

FOUR DAY ATTENDENCE AND TRAINING GUIDELINE: DAY ONE AND TWO - INTRODUCTION TO DERMAL FILLERS Day one Arrive and coffees (10.00) Registration, introduction and expectations (10.00-10.15) Structure of the training (10.15-10.30) Break (10.30-11.00) Lectures and interactive workshops / simulation (11.00 - 1230pm) Health and safety in the workplace Sharps injury and disposal The consultation process and prescriptions LUNCH (1300-1730) with a coffee break Basic life support Anaphylaxis - recognition and management Emergency kits - what it should contain and how to buy one Your doctors on call - how to contact our on call doctors for emergency advice How to use Hyalase safely - when to use it / recognise mechanism of action, how prescription in an emergency works and how to give the hyalase Practical and to include demonstration of Hyalase injection Our added benefits services for safety and convenience Day two Arrive and coffees (10.00) introduction and expectations (10.00-10.30) Structure of the training (10.30-11.00) Formal written examination covering key areas of THEORY for Dermal Filler injections: Anatomy, Physiology, Products and Complications. This will highlight early on if any important areas need to be covered in more detail for the students (11.00 - 1200) - Break for lunch - Practical session commences - (12.30 - 1800) - and in total on average we have scope for one model per 30 minutes on both of the Dermal filler days, so that’s a potential for 10 in total for a class size of maximum 4, which will give good hands on experience, as the way we train is to allow several people the opportunity to be involved with each patient - e.g. splitting into the phases of treatment, which allows the trainees to understand the concept of the treatment process. That would be - consultation, consent, marking up, readying equipment, performing the injection, providing advice and aftercare. DAY THREE AND FOUR BOTOX FOUNDATION COURSE Day three Arrive and coffees (10.00) introduction and expectations (10.00 – 10.30) Structure of the training (10.30 – 11.00) Formal written examination covering key areas of THEORY for Botox Application: Anatomy, Physiology, Products and Complications. This will highlight early on if any important areas need to be covered in more detail for the students (11.00 - 1200) - Break for lunch - Practical session commences - (12.30 - 1800) - and in total on average we have one model per 30 minutes on both the botox and days, so that’s a potential of 10 in total for a class size of 4, which will give good hands on experience, as the way we train is to allow several people the opportunity to be involved with each patient - e.g. splitting into the phases of treatment, which allows the trainees to understand the concept of the treatment process. That would be - consultation, consent, marking up, readying equipment, performing the injection, providing advice and aftercare. Day four Observed Treatment Process Examination The participants will be tested on the following key facets of safe practical care: Consultation process - rapport and understanding what the client wants Safe consent Marking and photographs Technical skill of injection Atercare provision and safety netting (eg if this happens do this / call me) 1 model will be provided for Botulinum (3 area) treatment and 1 - 2 clients for filler to ensure that each of the key anatomical areas covered are observed. Morning = Botulinum (0900 - 1230) Afternoon = Botulinum and Option Dermal fillers (1330 - 1630) Conclusion Candidates given session and refreshments and discussion regarding Case Studies and further support. (1700 - 1800)