The Medical Device Classification webinar explains the classification system in the US, the EU, following the Medial Device Directive (MDD), and the Canadian Medical Device Regulations (CMDR), and the guidance from the Global Harmonization Task Force (GHTF). This is a risk based approach implemented by regulatory authorities.
Areas Covered in the seminar:
* The Concepts Of Medical Device Risk
o Factors that may impact risk
o Regulatory controls keyed to risk
* Classification in the US
o Device Class
o Device Panel
o Device type regulation
o Controls
+ General Controls
+ Special Controls
+ Pre-market Approval
o FDA Guidance documents
o Recognized consensus standards
* Classification in the EU (MDD)
o Rule based system in MDD Annex IX
o Changes after March 2010
o Device class and the EU modules
o MDD Essential Requirements (Annex I)
o Harmonized standards
* Classification in Canada
o Rule based system in CMDR Schedule 1
o Specific requirements by device class
* GHTF Guidance
o Rule based system in the classification guidance
o Linkage to the Conformity Assessment guidance
Please contact Customer Care to avail 15% Christmas Offer on Regular Pricing (650-620-3937)
Send to friendSign In to get started!
