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Online Training - Medical Devices Regulatory Affairs with Experience Certification & Placement Assistance, Medical Devices Regulatory Affairs training certificate course in Hyderabad, India consists of online Medical Devices Regulatory Affairs training for the students across the Globe to Countries like India, USA,UK, Australia, Germany, Sweden, Netherlands, Singapore, Europe and Canada over World Wide Web. Medical Devices online Regulatory Training also offered in Hyderabad, Chennai, Bangalore, Mumbai, Pune, Delhi, Kolkata. BioMed Informatics Medwin Hospitals Online Training complimented as the best Medical Devices Regulatory Affairs Training in Hyderabad, best Medical Devices Regulatory Affairs Training in Chennai, best Medical Devices Regulatory Affairs Training in Bangalore, best Medical Devices Regulatory Affairs Training in Mumbai, best Medical Devices Regulatory Affairs Training in Pune, best Medical Devices Regulatory Affairs Training in Delhi, best Medical Devices Regulatory Affairs Training in Kolkata, best Medical Devices Regulatory Affairs Training in India. Medical Devices Regulatory affairs online training institute features include Interactive one to one online live sessions, one faculty/student, Regular/Fast track/Weekend, Flexible timings, Online Training via Skype/TeamViewer with course material and resume preparation tips.

Online Training - Medical Devices Regulatory Affairs with Experience Certification & Placement Assistance

BioMed Informatics Medwin Hospitals, Hyderabad, India is a leading Clinical Research Organization offering best Medical Devices Regulatory Affairs Training in Hyderabad since the year of 2000. Online Medical Devices Regulatory Affairs Training in Hyderabad, India includes best Regulatory Affairs Training in Medical Devices online Institute that imparts knowledge about Medical Device Regulations. Medical Devices Regulatory Affairs certificate course is valuable for professionals to scale up their career. BioMed Informatics Medwin Hospitals Online Training complimented as the best Medical Devices Regulatory Affairs Training in USA, best Medical Devices Regulatory Affairs Training in UK, best Medical Devices Regulatory Affairs Training in Australia, best Medical Devices Regulatory Affairs Training in Germany, best Medical Devices Regulatory Affairs Training in Sweden, best Medical Devices Regulatory Affairs Training in Netherlands, best Medical Devices Regulatory Affairs Training in Singapore, best Medical Devices Regulatory Affairs Training in Europe, best Medical Devices Regulatory Affairs Training in Canada. Training in Online Regulatory Affairs in Medical Devices is very much helpful for the professionals planning to switch over their jobs or even for fresh jobs too. With the rising innovations and the rapid growth in healthcare sector, the demand for Medical Devices Regulatory Affairs Professionals has been increased.

Medical Devices Regulatory Affairs professionals are the link between Medical Devices industries and worldwide regulatory agencies like USA, UK, Canada, European Union, India, Japan, Australia. Healthcare industry, being one of the highly regulated industries, is in immense need of people than ever before who are capable of handling issues related to regulatory affairs in a comprehensive manner. Regulatory affairs professionals play an essential role in ensuring all Medical Devices comply with regulations governing the industry. Regulatory professionals employed in industry are involved with a wide range of medical devices made in various countries. As regulatory processes increase in complexity and scope, and globalization occurs within the field, there will be continuing industry demand for people with a strong foundation in Medical Devices regulatory affairs. The Regulatory Affairs program provides professionals with the specialized knowledge required to help biotechnology, medical device, pharmaceutical and food companies manage regulatory processes.

Online Training Features

  • Web based classroom
  • One faculty/student
  • Placement support
  • Regular/Fast track/Weekend individual slot
  • Flexible timings
  • Training Mode: Skype/Teamviewer

Certification

Course Certificate & Job Experience Certificate would be awarded at the end of the program.

Course Curriculum

  • Medical Devices Regulatory Affairs - MDRA
  • Overview of Regulatory Requirements : Medical Devices
  • FDA / CDRH Functioning
  • Medical Device Classification
  • Devices / Device Panels / Regulation Product Codes
  • 21 CFR Parts 800-1299
  • Product Classification Database : 21 CFR Parts 862-892
  • Distinct Product Code Identification Procedure
  • Total Product Life Cycle (TPCL) / TPCL Product Code Report
  • General controls and Special controls
  • Pre-market approval – PMA
  • Adulteration
  • Misbranding
  • Electronic Establishment Registration
  • Pre-market notification submission 510(k)
  • 510(k) Marketing clearance process
  • Medical Device Exemptions 510(k)
  • FDA Clearance
  • Medical Device Reporting – MDR
  • Special labeling
  • Establishment Registration and Medical Device Listing
  • Reserve Devices
  • Special 510(k)
  • Abbreviated 510(k)
  • Substantial equivalence
  • Medical device labeling
  • Post-market studies
  • Medical device tracking
  • Comparative Study :
  • Medical Device Regulations in USA
  • Medical Device Regulations in European Union
  • Medical Device Regulations in India