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
  • 146 vues
US FDA Consulting for Medical Device and IVD Manufacturers
US FDA Consulting for Medical Device and IVD Manufacturers
  • 19 vues
What is the USFDA criteria Clinical trial models are based on
What is the USFDA criteria Clinical trial models are based on
  • 9 vues
Configuration Management and Product Configuration in the Medical Device Industry
Configuration Management and Product Configuration in the Medical Device Industry
  • 16 vues
3 Steps medical device Merger and acquisition compliance review.
3 Steps medical device Merger and acquisition compliance review.
  • 12 vues
What is Remediation FDA
What is Remediation FDA
  • 7 vues
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
  • 83 vues
When should you start a QMS
When should you start a QMS
  • 11 vues
When should you start a QMS
When should you start a QMS
  • 5 vues
QMS documentation of Medical Devices.
QMS documentation of Medical Devices.
  • 10 vues
Process Validation for medical devices
Process Validation for medical devices
  • 17 vues
Clinical Evaluation for Medical devices
Clinical Evaluation for Medical devices
  • 60 vues
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 vues
cloud based distribution software
cloud based distribution software
  • 5 vues
Difference between Form 483 observation & warning letter
Difference between Form 483 observation & warning letter
  • 14 vues
Do you know about risk management for medical devices
Do you know about risk management for medical devices
  • 10 vues
Have you chosen correct FDA Regulatory Pathway for Your Medical Device?
Have you chosen correct FDA Regulatory Pathway for Your Medical Device?
  • 11 vues
Have you asked these questions to QMS Software Vendors in medical devices?
Have you asked these questions to QMS Software Vendors in medical devices?
  • 12 vues
Advantages & Disadvantages of 3D printing in Medical Devices.
Advantages & Disadvantages of 3D printing in Medical Devices.
  • 11 vues
How to Determine your Device Class
How to Determine your Device Class
  • 11 vues
FDA 21 CFR PART 820
FDA 21 CFR PART 820
  • 361 vues
Ways tomake your medical device available in the US market
Ways tomake your medical device available in the US market
  • 7 vues
Design with the end user in mind
Design with the end user in mind
  • 6 vues
Risk Mitigation, an Important aspect in Software used in Medical device Industry
Risk Mitigation, an Important aspect in Software used in Medical device Industry
  • 10 vues
How to Prepare Your Content for Medical Device Translation
How to Prepare Your Content for Medical Device Translation
  • 0 vues
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.
  • 9 vues
Questions about the European MDR answered
Questions about the European MDR answered
  • 5 vues