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Introduction to ISO 13485 - How to build and maintain an effective quality system for a Medical Device Company
Date: 2.-3.5.2011
Location: Rantasipi Airport Congress Center, Robert Huberin tie 4, 01510 Vantaa
Background and scope of course
The objective of the course is to create a basic understanding for the standard ISO 13485, which is the quality framework for the Medical Device manufacturers. The course will cover regulations, standards, design control and risk management relevant for MDD/IVDD devices and the classification system for MDD/IVDD products.
Who should attend?
Quality management, R&D management, quality engineers and process engineers for Medical Device companies that need to:
- Implement a Quality system according to MDD
- Update the current quality system, e.g. manufacturers of stand-alone SW migrating from ISO 9001 to 13485
- Improve the quality system to be competitive on the market
Course benefit
The objective of this course is to give an understanding of the issues presented by ISO 13485 from initial product development through the product life time on the market. It covers all parts of ISO 13485 and gives both underlying rationales for content in the standard and hands-on examples of the implementation.
Course content
- General overview on how ISO 13485 is positioned in the regulatory landscape
- Other relevant harmonized standards
- Global trends and what's new - GHTF and similar initiatives
- Quality system implementation - issues to consider and be aware of when implementing a quality system
- Scope and definitions
- Management responsibilities
- Resources
- Product development
- Measurements, analysis, improvements
- Comparison to ISO 9001
- Comparison to FDA QSR
Course schedule
2.5. kl 8.30 - 17.30 & 3.5. kl 9.00 - 16.30
Course language
The course will be conducted in English.
Course instructor
Robert Ginsberg, Synergus AB - Senior Expert - Lean SW Development and Design Control.
More information >>
Course fee
1000€/700€* (* FiHTA member companies). VAT 23% shall be added to the fee. The fee includes: lectures, course materials, coffee and lunch.
Registration
Submit the registration form via this link by Friday April 22nd, 2011.
Cancellation policy
Cancellation of registration prior to the commencement of the event: 7 days or less, 50 %. If no cancellation, full fee.
For more information
terhi.kajaste@teknologiateollisuus.fi , tel: +358 50 576 5536
Rights to changes reserved.
Wellcome!
