Certification Program - Medical Device Regulatory Affairs

Global Institute of Regulatory Affairs
In Pune

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Important information

  • Certificate
  • Pune
  • Duration:
    3 Months
  • When:

This training course has been developed for those who are involved with ensuring regulatory compliance for medical devices. The course is primarily geared towards those who are new to industry or require a basic understanding of medical device regulatory compliance issues. It is also uselful to industry veterans who need extra training on these topics and to clear basic concepts

This Course is desgined for individuals who need basic, but through understanding of all the validation in pharma industry.
It will help to understand the fundamentals and concepts of Pharma Validation.
Overview and understanding of Pharma validaion, how to organize and carry out the same & the Key areas to Look forward in the whole process

Important information

Where and when

Starts Location Timetable
Prestige Classic BLD - Dwing Off no G4 & 5, CHinchwad station Chinchwad Pune, 411019, Maharashtra, India
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Frequent Asked Questions

· Qualification

Graduates in any stream are eligible to apply.

What you'll learn on the course

Medical Device Manufacturers
Regulatory Affairs Professionals
Quality Assurance
Quality Control People
Marketing Personnel Involved in Medical Device
Labelling of Medical Devices
CE Marking

Teachers and trainers (1)

Global Institute of Regulatory Affairs
Global Institute of Regulatory Affairs
Drug Regulatory Affairs

Course programme

This course is specifically focused on the law, regulations and policies set by the regulatory bodies for the pre-market approval, manufacture and post-marketing compliance of medical devices. (US, EU)The course content is designed to provide an in-depth understanding of the ways to obtain the agency approvalIt also provides FDA strategies towards inspections of manufacturing sites, and compliance actions that may result from these inspectionsTopics CoveredToptopWhat are Medical Devices?Classification of Medical devices - USA- Europe- IndiaExporting & Registeration of Medical devices - USA- Europe- India510k SubmissionCE MarkingQMS & ISO for Medical DevicesLabelling of Medical DevicesWho Should Apply
Medical Device ManufacturersRegulatory Affairs ProfessionalsPeople Involved in Product Design,Research & DevelopmentQuality Assurance & Quality Control PeopleMedical/Marketing Personnel Involved in Medical Device

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