Medical Devices Course

SGS India Private Limited
In Mumbai

Price on request

Important information

  • Course
  • Mumbai
  • Duration:
    3 Days

Important information

Where and when

Starts Location
On request
SGS House, 4B, A.S.Marg Vikhroli (West), 400083, Maharashtra, India
See map

Course programme

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

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