Medical Devices Course

SGS India Three Days program on "Prerequisites for EU Directive 93/42/EEC on medical technology and quality systems of medical devices-ISO 13485 and Medical technology Directives.

Syllabus Ist day is in the "Prerequisites for EU Directive 93/42/EEC on medical devices" with one goal:

* Know about the important aspects of 93/42/EEC
* Understand the Structure of the Medical Devices Directive
* Know about the documentation Prerequisites of the 93/42/EEC
* Prepare you about relevant direction documents
* Learn establish a technological documentation for Class I, IIa devices, IIb, III

Syllabus IInd days is for Quality Systems for Medical devices : ISO 13485 and the Medical Devices Directives with one goal:

* Know about the Prerequisites of ISO 13485:2003
* Learn about the quality system Prerequisites of Directive 93/42/EEC
* To value the role of guidance documents
* Prepare you use this information to design quality systems and procedures appropriate
* In order to carry out audits of first, second and third against the rules
* Understand Risk Assessment

Profile:
The program meets the learning prerequisites of EU Directive 93/42/EEC on medical devices and quality management system ISO 13485 for medical devices and features interactive sessions, classes and role-play practices. Candidates should have some fundamental knowledge related to medical devices