GIRA-Regulatory Affairs Courses

(+91) 9595750750

Apply Online
  • captchaimg

Online Medical Device Regulation Training

Medical Device Regulation Compliance Training

About Course

This online medical device compliance 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

medical-device
  • To understand USFDA/EU/Indian CDSCO Regulation for Medical Devices.
  • To help comply with Quality and Regulatory requirement for Medical Devices Sector.
  • Overview and understand Medical Device Regulation and compliance requirement

Scope

  • 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 approval
  • It also provides FDA strategies towards inspections of manufacturing sites, and compliance actions that may result from these inspections

Topics Covered

  • What are Medical Devices?
  • Classification of Medical devices - USA- Europe- India
  • Exporting & Registeration of Medical devices - USA- Europe- India
  • 510k Submission
  • CE Marking
  • QMS & ISO for Medical Devices
  • Labelling of Medical Devices

Who Should Apply

  • Medical Device Manufacturers
  • Regulatory Affairs Professionals
  • People Involved in Product Design,Research & Development
  • Quality Assurance & Quality Control People
  • Medical/Marketing Personnel Involved in Medical Device

Eligibility

Graduates in any stream are eligible to apply.

Duration & Fees

  • Course Duration : 3 Months
  • Fees: Rs 16,600-/

Apply Online

Students can download the admission form by clicking here, in PDF format print and fill the same, clearly mentioning Mobile No & Course Interested.The Filled form should be courried to us along with DD at the below mentioned address.

Address:
Global Institute of Regulatory Affairs
Prestige Classic BLD,
D Wing Off G4 & 5,
Chinchwad Station,
Near Dawabazar,
Chinchwad Pune - 19
Phone – 020-46704472

Apply Online

Our Courses

Testimonials

    Nakul Pathak Says

    "Regulatory Affairs program at GIRA very effectively integrates industrial experiences with academics in the pharmaceutical field. It helps you to understand the Practicalities of the rules, regulations & guidelines ."

    Nikhil Pachpute Says

    “GIRA's training institute offers high quality courses. It gave me a much needed broader perspective and a multi- faceted view of regulatory affairs. I understood the department work in depth and got a breakthrough in Regulatory Sector."

    Arun Renukuntla Says

    "Faculty at GIRA has vast industrial experience, which has been very useful for me. The teaching methodology is very innovative as well as interactive. Dedicated sessions for query solving are also there.”

E-learning

full-time-courses