#619 Obtaining the CE Mark
Course Content: This course on CE Marking Requirements will cover all aspects of obtaining the CE mark for your products. The following sub topics will be covered:
The EC Directive process and CE marking
Background of the new approach directives, The role of notified bodies and competent authorities, MDD Requirements, Authorized representative, Device Classification
Device classification – Case Study
Conformity Assessment
Conformity Assessment Options, Technical Files, Design Dossiers, Type Exams, Format, control, common issues, MDD Annex I essential requirements / Harmonized standards, General requirements, Design requirements, Labeling, Clinical Data.
Conformity Assessment / Contract Manufacture – Case Study
MDD Future Updates / Revisions / Current Status
http://www.acteva.com/booking.cfm?bevaid=186691
Quality System Requirements (ISO 13485/MDD)
ISO 13485:2003, Risk Management / ISO 14971, Auditing MDD Requirements.
Vigilance requirements
Reporting, What should be reported? Who to report to
Vigilance Case Studies
Examination
Wrap Up / Review Exam
Course Length: 4 Hours
Course Instructor: Connie Hoy
Instructor Bio:
Connie Hoy joined Xoft, Inc as VP RA / QA in December, 2007. Prior to that she spent over 12 years working in the medical laser industry, as VP RA/ QA at Cutera, Inc and prior to that VP RA / QA at Lumenis, Inc.
Connie began her career 22 years ago at a start-up company that developed sterile implantable devices. During her 8 years at Oco Biomedical, she served as the President of the Dental Implant Manufacturer’s Association and the Southwest Biomedical Coalition. In 1995 she joined Tissue Technologies as the Director of Regulatory Affairs, where she led the effort to become one of the first ISO 9001 / EN 46001 certified medical companies in the US. Connie was also an industry representative on the advisory board that consulted with FDA on the implementation of the 1996 revision of the Quality System Regulations.
Connie then joined Cell Robotic, Inc where she obtained the first 510(K) clearance for a medical laser device to be sold into the home. The device was used for obtaining capillary blood samples for diabetes testing. Outside of the office, Connie is the mother of 4 adult children, loves to cook and is a scuba diving instructor.
Email: choy@xoftinc.com
