This CE Mark training class can be conducted on-site by a member of Emergo's team of quality and regulatory professionals. Our CE 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, regardless of how many employees attend.
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 that every employee is receiving consistent information at the same time.
What your team will learn in this intensive one-day CE training class:
- Which medical devices are within the scope of 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 harmonized European standards.
- Compiling a Technical File.
- Conducting a risk assessment.
- 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.
This one-day training class can be combined with our other classes on country regulations, ISO 13485 or internal auditing.
Please contact us for more information on CE Marking training at your facility.