Managing Your Complaints and Obstacles in Post-Market Requirements -- Results from Top Medical Device Observations During an Inspection

  • Conference / Seminar in Massachusetts, USA
  • On: 2019/11/14 8:30 To: 2019/11/15 16:00
Post-Market activities, Complaint Handling, MDRs, and Recalls are expensive, time consuming, and often lead to more serious financial consequences. Over 80% of FDA Inspection target observations for lack of compliance ...

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Navigating through Maze of In-vitro Diagnostics (IVD) Regulations: A systematic approach from Regulatory Strategy to Regulatory Approvals in U.S./Europe/Canada

  • Conference / Seminar in Massachusetts, USA
  • On: 2019/10/14 8:30 To: 2019/10/15 16:30
In-vitro Diagnostics (IVD) products provide critical information on patient’s health condition, based on which the healthcare provider develops and administers treatment plan. Although IVDs are medical devices, they are regulated ...

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Analytical Instrument Qualification and System Validation : 2-Day In-Person Seminar

  • Conference / Seminar in Massachusetts, USA
  • On: 2019/09/19 8:00 To: 2019/09/20 16:00
Analytical equipment should be qualified, and computer systems should be validated to demonstrate suitability for their intended use. To be acceptable to regulatory authorities, electronic records must comply with 21 ...

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Biocompatibility Testing for Medical Devices : One and a Half Day In-Person Seminar

  • Conference / Seminar in Massachusetts, USA
  • On: 2019/12/05 8:30 To: 2019/12/06 16:30
The medical device field is one of the most heavily regulated industries, for obvious reasons. Medical devices are an important tool in efforts to improve patient care and treatment outcomes. ...

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Navratri Festival 2018

The Navaratri festival celebrated in the months of September thru November is a festival of worship, dance and music celebrated over a period of nine nights. The Dandiya is the traditional, folk dance performed with great fervor and enthusiasm. Young ......