Are you a medical device specialist working with clinical and regulatory affairs or quality assurance? Then the Qmed Academy is for you!
Bringing a new medical device to the market, requires that you master certain skillset and competences - and can document them. As a start-up or even a larger organisation, it might be difficult to find the right path and develop the documentation required to obtain market approval and the company is at risk of losing important deadlines. The road to approval is long and difficult, but at the Qmed Academy, we will show you how to get there.
About the education?
The requirements of bringing medical devices to the market are many and can be difficult to navigate within. As that wasn’t enough, the requirements are currently undergoing great changes with the imminence of the Medical Device Regulation. Therefore, it is important that you, as a medical device specialist, understands the requirement, on how to navigate and, most importantly, how to practical implement these requirements into your thought process and documentation.
This course is tailor-made for medical device specialists within medical device development. Presumably, you are either:
- working in a small organisation and need support in implementing the requirements specifically for your device
- or sitting as leader in a larger or midsized organisation and are having difficulties setting aside resources to train new and more inexperienced employees.
Why is it important?
Medtech is a cornerstone of the Danish economy and brilliant ideas and business opportunities are arising every day. The success has a back side and that is availability of competent resources that can navigate and support the process of putting medical devices on the market.
The goal of the Qmed Academy is to give the participants the ability to create solutions for their own ideas and projects — ultimately, enabling better health for patients around the world.
Qmed have established an environment where clients are being hands-on trained and coached how to maneuver through;
- quality assurance,
- regulatory affairs and
- clinical affairs
-developing and putting a medical device on market.
We take care of your or your employees training, including daily tasks during weekly coaching, support, supervision, training and knowledge sharing at the Qmed facilities in Copenhagen. Output will be fully implemented into your company.
Some of things we’ll cover are:
- How to build up a Quality Management System (QMS) and the Technical Documentation (TD)
- How to create your submission to the Authorities in key markets such as EU and US (Regulatory Affairs)
- How to set up and manage a clinical investigation with devices
You or your employees will be provided with enough support to continue until next weekly session with the Academy team. All participants in the Qmed Academy will have access to daily support on phone or mail.
By joining the Qmed Academy, you will get access to the templates and procedures of relevance for your project and to the specialist network of the Qmed Academy.
Fill out the form below if you are interested in joining the Qmed Academy program. We will establish teams of at least three people, with relevant backgrounds and experience.
The class runs for 6 months and new classes are started up March 1st and September 1st. The application process stops end June and end January.
Each period will be started up with a kickoff meeting setting the milestones and deliveries specifically for your project and company.
Helene Quie, Owner of Qmed Consulting A/S, co-founder of Qmed Academy and senior advisor. Helen has 25 years of experience in the medical device industry, supporting companies from start-up to well established companies.
Randi Hauerberg, co-founder of Qmed Academy and Consultant and owner at RA/QA Aid Consulting, acting as a RA/QA expert with more than 20 years of experience in the industry, supporting companies.
Lea Jess Tjell Rasmussen, co-founder of Qmed Academy, senior advisor at Qmed consulting A/S, certified coach and with more than 15 year of experience supporting pharma, biotech and device companies.
Do not hesitate to make contact!
Phone: +45 6025 6980
Show us your interest here
Fill out the form, if you’re interested in learning more about the Qmed Academy and what it can do for you. You will be contacted shortly thereafter.