CE Mark Training for EU Medical Device Regulations
ANSWERED ON THIS PAGE:
- Why does our team need CE Marking training?
- Who should attend CE Marking training?
- What will we learn?
To sell your product in Europe, it must bear the CE Mark. The CE Marking process is well established, but mistakes can be costly. Emergo's CE Mark training is designed for key members of your team working to get your device on the European market. Our CE Mark training consultants have extensive experience and will deliver a high-quality training session tailored to the needs of your organization.
Professional, on-site CE Marking training for one fixed fee
This CE Mark training class can be conducted on-site by a member of Emergo's team of quality and regulatory professionals. Our fee for this training is based on a set daily fee plus expenses. This makes it an excellent value for medical device companies that need to train more than two employees at one time.
Our on-site training gives your employees the opportunity to ask questions (something they can't do easily with public or online classes) and ensures every employee receives consistent information.
What your team can learn in this intensive CE training class:
- The new Medical Device Regulations
- Background on the Medical Device, IVD and Active Implantable Directives
- Steps to CE Marking compliance
- Device classification
- The conformity assessment route for Class I, IIa, IIb and III products, or Annex II, List A; Annex II, List B; or self-testing IVD
- Review of ISO 13485, ISO 14971, and other harmonized European standards
- Compiling a Technical File and Clinical Evaluation Report (CER)
- Conducting a risk assessment
- Labeling and language translation issues
- Selection of a Notified Body and when they are necessary
- Role of the EU Authorized Representative
- Post market surveillance, including vigilance
- Requirements for the Declaration of Conformity
We will also customize the course content to the needs of your company, device type, and personnel. This one- to two-day training class can be combined with our other classes on country regulations, ISO 13485, or internal auditing.
How long is the training?
Training usually starts at 9am each day and runs until 5pm, with breaks in the morning and afternoon, and one hour for lunch. However, this can be changed to suit your specific business needs.
Who should attend the training?
The training is appropriate for all levels of employees, from upper-level management to assembly line staff.
Can we host the training off-site?
We recommend conducting the training at your facility. It saves cost, eliminates additional travel for attendees, and allows your employees to openly discuss your company’s concerns.