CE Marking Training for Medical Device & IVD Companies - 1 DAY
This CE Marking training class is conducted on-site by a member of Emergo Group’s team of quality and regulatory professionals. Our training consultants have real world manufacturing experience and are not professional “canned” presenters that travel from city to city. This ensures that your team will get a high quality training session tailored to the needs of your organization.
Professional, on-site CE Mark / CE Marking training for one fixed fee, regardless of how many employees attend!
Our fee for training is based on a set daily fee plus expenses. This makes it a great value for companies that need to train more than two employees at one time. On-site training gives your employees the opportunity to ask questions (something they can’t do easily with online classes) and ensures that every employee is hearing consistent information at the same time.
What your team will learn in this intensive one day CE Mark training class:
- What products are within the scope of the Medical Device, IVD and Active Implantable Directives.
- Basic steps to compliance.
- Discussion of each product class: 1, 2a, 2b, 3.
- Defining the duration of contact and invasiveness with the patient.
- The conformity assessment route for Class 1, 2a, 2b and 3 products.
- Review of harmonized European standards.
- Compiling a Technical File.
- Conducting a risk assessment.
- How to choose a Notified Body and when they are necessary.
- Role of the Authorized Representative.
- Importance of vigilance.
- Requirements for the Declaration of Conformity.
If you are interested in having Emergo Group conduct this CE marking training class for your company, please feel free to contact us.
