Outcome
Would you like to understand what it takes to perform a successful market launch of your medtech solution? At this course you will learn to understand the possibilities and challenges getting a new medical device from the idea to market launch - and you will understand how to do it in practice including tools like “Validation of product idea”, “Evaluation of business potential”, “Identification of potential customers”, “Regulatory overview and authority expectations”,  “How to prepare and organize the technical file” and finally “How to ensure market positioning”.
 
You will be provided with a structured roadmap to process the complex commercial and regulatory elements needed to gain success in the market, which can be applied to both start-ups and international companies already on the market with other products.

Content
Compliance Plan

• Notified body
• Classification clarification
• QMS

 Commercialisation

• Validation of product idea
• Evaluation of business potential
• Identification of potential customers
• Market positioning
• Evidence based communication

 Design Control

• Device documentation & test
• Biological evaluation (BEP/BER)
• Clinical evaluation (CEP/CER)
• Clinical investigation

 Design transfer

• Logistic setup and authority requirements
• Manufacturing qualification activities
• Education & Training

Who should attend?
The course is targeted towards professionals who are involved in the following areas:

• Development of medical devices
• Quality Assurance
• Regulatory Affairs
• Project Management
• Medical Market Access
• Marketing
• Persons who will like to have the total overview of the medical device business

There are no pre requisites but it is helpful to have experience from the medical device industry.
 
Trainers
Søren Lyngsø-Petersen, CEO, Pharma4ever QA ApS
Susie Wagner, Owner, Infocura