ISO 13485, ISO 9001 and QSR Regulations for Medical Device Companies

The Center for Professional Advancement
Amsterdam, Netherlands

Course Format: Classroom | E-learning | Virtual Class | Online | On-site | Blended | Self-paced

Course Description:

'' This course provides a detailed description of the current European and US regulations for medical devices. With the continued growth in the development and acceptance of global standards, all device companies must stay up to date on the various regulations to ensure marketability of their products globally. With 25 European countries now using the ISO 13485 standard, it is critical to companies to understand how the similarities and differences in these standards can be implemented into their own quality system to enhance their marketability. The primary focus of this course is on the development of one quality system which complies with the ISO 13485:2003 standard, ISO 9001:2000 standard and the FDA Quality System Regulations. Participant interaction, problem solving and open discussion will be strongly encouraged.


Participants who work in the medical device industry and who currently are or wish to sell their product in the US, Europe and other parts of the world will profit by attending this course. This includes professionals responsible for understanding and interpreting global regulations within their companies, in areas such as:

Regulatory
QA
R&D
Manufacturing
...''

Phone:+31/20/638.28.06

School Address:

Corporate Office
Box 7077, 44 West Ferris Street
East Brunswick, NJ USA 08816-7077
Phone: (732)238-1600
Fax: (732)238-9113
Email info@cfpa.com

Europe Office
Oudezijds Voorburgwal 316A, 1012 GM
Amsterdam, The Netherlands
Phone +31/20/638.28.06
Fax +31/20/620.21.36
Email amsterdam@cfpa.com



Jobs & Resumes: Amsterdam
Houses & Roommates: Amsterdam

Microbiological Control and Validation
Critical Process Cleaning and Cleaning Validation
Clean Room Technology
Powder Mixing Technology
Auditing for cGMP Compliance
Starch: Chemistry, Properties and Applications
Food Extrusion Technology
Complaint Procedures for Medical Devices
Microencapsulation and Particle Coating
Nanotechnology
Project Management
Risk Analysis & Human Factors Engineering
Gums and Hydrocolloids
Microencapsulation and Particle Coating
Documentation Management and Control
Analytical Methods Validation for FDA Compliance
Drug Product Stability and Shelf-Life
Microbiological Control and Validation
Process Validation for the Pharmaceutical and Medical Device Industry

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