IZiel Group's Uploads

107 Uploads

FDA form 483 observations and warning letters - what is the difference
FDA form 483 observations and warning letters - what is the difference
  • 71 views
US FDA Consulting for Medical Device and IVD Manufacturers
US FDA Consulting for Medical Device and IVD Manufacturers
  • 10 views
What is the USFDA criteria Clinical trial models are based on
What is the USFDA criteria Clinical trial models are based on
  • 6 views
Configuration Management and Product Configuration in the Medical Device Industry
Configuration Management and Product Configuration in the Medical Device Industry
  • 8 views
3 Steps medical device Merger and acquisition compliance review.
3 Steps medical device Merger and acquisition compliance review.
  • 11 views
What is Remediation FDA
What is Remediation FDA
  • 5 views
IQ, OQ, PQ What do they mean And why are they important in medical device manufacturing
IQ, OQ, PQ What do they mean And why are they important in medical device manufacturing
  • 61 views
When should you start a QMS
When should you start a QMS
  • 10 views
When should you start a QMS
When should you start a QMS
  • 5 views
QMS documentation of Medical Devices.
QMS documentation of Medical Devices.
  • 6 views
Process Validation for medical devices
Process Validation for medical devices
  • 5 views
Clinical Evaluation for Medical devices
Clinical Evaluation for Medical devices
  • 34 views
MDD to MDR Part 2- How you help yourself –How consultant can support you
MDD to MDR Part 2- How you help yourself –How consultant can support you
  • 12 views
cloud based distribution software
cloud based distribution software
  • 5 views
Difference between Form 483 observation & warning letter
Difference between Form 483 observation & warning letter
  • 4 views
Do you know about risk management for medical devices
Do you know about risk management for medical devices
  • 5 views
Have you chosen correct FDA Regulatory Pathway for Your Medical Device?
Have you chosen correct FDA Regulatory Pathway for Your Medical Device?
  • 9 views
Have you asked these questions to QMS Software Vendors in medical devices?
Have you asked these questions to QMS Software Vendors in medical devices?
  • 9 views
Advantages & Disadvantages of 3D printing in Medical Devices.
Advantages & Disadvantages of 3D printing in Medical Devices.
  • 6 views
How to Determine your Device Class
How to Determine your Device Class
  • 9 views
FDA 21 CFR PART 820
FDA 21 CFR PART 820
  • 261 views
Ways tomake your medical device available in the US market
Ways tomake your medical device available in the US market
  • 3 views
Design with the end user in mind
Design with the end user in mind
  • 2 views
Risk Mitigation, an Important aspect in Software used in Medical device Industry
Risk Mitigation, an Important aspect in Software used in Medical device Industry
  • 6 views
How to Prepare Your Content for Medical Device Translation
How to Prepare Your Content for Medical Device Translation
  • 0 views
Compliance Officers QA & RA: What They Do and Why They are in Demand.
Compliance Officers QA & RA: What They Do and Why They are in Demand.
  • 4 views
Questions about the European MDR answered
Questions about the European MDR answered
  • 2 views