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Certification
What is a certification?
Preparation for a certification (which requirements shall I meet?)
Technical File
Harmonised standards
Essential Requirements
Declaration of Conformity
Certification process
Medical devices
Quality management systems
CE-Marking
What is CE marking?
The route to CE-Marking
Classification of medical devices (which risk class is my medical device?)
Conformity assessment (which procedure applies for my device?)
Conformity assessment - Class I
Conformity assessment - Class Is/Im
Conformity assessment - Class IIa
Conformity assessment - Class IIb
Conformity assessment - Class III
Medical Device Directive 93/42/EEC
ISO 13485
What is ISO 13485?
Risk management
Requirements for the ISO 13485 certification
Difference between ISO 13485 and ISO 9001
Questionnaire Quality Management
International
International Certifications
Canada
Japan
Taiwan
Greece
About us
Who we are
Our history
Our services
Your benefits of Medcert Certification
Our team
References
Download Center
Download Center
Medcert Documents
Standards and Legislation
Links
Index
Contact
Contact us
How to find us
Home
Download Center
Links
Links
BfArM - Federal Institute for Drugs and Medical Devices
BVMed - German Medical Technology Association
Department of Health, Taiwan
DIMDI - German Institute of Medical Documentation and Information
European Association of Authorized Representatives
European Association of Notified Bodies for Medical Devices
FDA -
U.S. Food and Drug Administration
Germanischer Lloyd AG
GHTF - Global Harmonization Task Force
GMDN - The Global Medical Device Nomenclature
Health Canada
MEDDEV - Guidelines relating to medical devices Directives
New Approach Standardisation in the Internal Market
NBOG - Notified Body Operations Group
PMDA - Pharmaceuticals and Medical Devices Agency
Robert - Koch - Institut (RKI)
TGA - German Association for Accreditation GmbH
ZLG - Central Authority of the Laender for Health Protection with Regard to Medicinal Products and Medical Devices