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The Only Indian Portal Site On  The Medical Plastics/Devices Technology And Trade

Download Registration Form / Download Program Schedule

Dear Sir,

Subject : One Day Seminar On " EU Medical Device Directives , Related Regulations and ICMED ” on following dates:

  • Hotel Royal Plaza, 19 Ashoka Road, Connaught Place, Delhi on 23 Aug 2016

  • The Pride Plaza Hotel, Judges Bungalow Road, Off S.G. Road, Ahmedabad on 24 Aug 2016

  • Hotel Fortune Select Palms, 142, Rajiv Gandhi Salai – Thoraipakkam, Chennai on 26 Aug 2016

  • Hotel The Lalit, Sahar Airport Road, Andheri Est, Mumbai on 27 Aug 2016

Under the Capacity Building Initiative for Trade Development in India (CITD) project, a 1-day awareness programme is organized highlighting the role of the Notified Bodies, the affixing of the CE marking and all relevant amended requirements contained therein, comparing to the Directives actually in place. It includes :

  • Introduction to the fundamentals of EU medical device regulation.

  • The Essential Requirements and Technical Documentation

  • The importance of ISO 13485 for Quality Management System (QMS) implementation and ISO 14971 to Risk Management.

  • Specific In Vitro Diagnostic (IVD) considerations to ensure robust compliance.

  • Clinical Evaluation of Medical Devices, including use of ISO 14155 for clinical investigation planning.

  • Post-Market Surveillance (PMS)

  • The new Medical Device and In Vitro Diagnostic Regulations

  • Presentation of the Indian Certification of Medical Devices Scheme (ICMED)

There is no registration fee for attending this programme. However, there is limited capacity of participants.

The nomination form along with the detailed programme is attached for your ready reference.

Please confirm your nomination with complete details as per the nomination form attached by 17 August 2016 to Mr. Sunil Jha ( suniljha@qcin.org ) with a copy to mpds00@vsnl.com.

Download Registration Form / Download Program Schedule

Kind Regards,

D L Pandya
CEO
Mobile : 98254 57563
MEDICAL PLASTICS DATA SERVICE
MEDISOURCEASIA.COM
B-4, Mandir Apt., Opp. P & T Colony, Nr. Jodhpur Char Rasta, Satellite Road, Ahmedabad - 380015, Gujarat, India
Phone : 0091-79-26740611, Telefax: 0091-79-26754867, Email: mpds00@vsnl.com or dlpandya@gmail.com


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