IZiel Group's Uploads

107 Uploads

Software Configuration Management Medical Device
Software Configuration Management Medical Device
  • 11 vues
Clinical Evaluation Report MDR Requirements
Clinical Evaluation Report MDR Requirements
  • 117 vues
Clinical Evaluation Report MDR Requirements
Clinical Evaluation Report MDR Requirements
  • 91 vues
Best Practices for Implementing Design Controls for The Medical Device Industry
Best Practices for Implementing Design Controls for The Medical Device Industry
  • 21 vues
Are you making these mistakes with FDA 21 CFR PART 820 made for medical devices
Are you making these mistakes with FDA 21 CFR PART 820 made for medical devices
  • 12 vues
Difference between Form 483 observation & warning letter
Difference between Form 483 observation & warning letter
  • 12 vues
What is an MDR Gap Analysis
What is an MDR Gap Analysis
  • 11 vues
What is an MDR Gap Analysis
What is an MDR Gap Analysis
  • 23 vues
What are the 6 Essentials of a Clinical Evaluation Report (CER)
What are the 6 Essentials of a Clinical Evaluation Report (CER)
  • 8 vues
Are you making these mistakes with FDA 21 CFR PART 820 made for medical devices
Are you making these mistakes with FDA 21 CFR PART 820 made for medical devices
  • 14 vues
Steps for Getting CE Marking
Steps for Getting CE Marking
  • 14 vues
FDA regulatory requirements for medical devices
FDA regulatory requirements for medical devices
  • 39 vues
Configuration Management and Product Configuration in the Medical Device Industry
Configuration Management and Product Configuration in the Medical Device Industry
  • 10 vues
Common Issues in Healthcare Mergers and Acquisitions
Common Issues in Healthcare Mergers and Acquisitions
  • 40 vues
Overview of Medical Device Process Validation and Regulatory Requirements
Overview of Medical Device Process Validation and Regulatory Requirements
  • 164 vues
Healthcare Merger &Acquisition What Decision Makers Need to Know Before Partnering
Healthcare Merger &Acquisition What Decision Makers Need to Know Before Partnering
  • 9 vues
Configuration Management in the Medical Device Industry
Configuration Management in the Medical Device Industry
  • 20 vues
Process Validation: Pharma Vs. Medical Device
Process Validation: Pharma Vs. Medical Device
  • 9 vues
USFDA Consulting for Medical Device and IVD Manufacturers
USFDA Consulting for Medical Device and IVD Manufacturers
  • 26 vues
6 Tips to avoid 483 letters
6 Tips to avoid 483 letters
  • 9 vues
5 Step to Risk Management for Medical Devices
5 Step to Risk Management for Medical Devices
  • 13 vues
MDR vs. MDD 13 Key Changes
MDR vs. MDD 13 Key Changes
  • 25 vues
6 Reasons to Get Expert Help When Handling Warning Letters & FDA 483
6 Reasons to Get Expert Help When Handling Warning Letters & FDA 483
  • 16 vues
US FDA Form 483 and Warning Letter Analysis, Response, and Recovery
US FDA Form 483 and Warning Letter Analysis, Response, and Recovery
  • 24 vues
Everything you need to know about FDA regulatory consulting
Everything you need to know about FDA regulatory consulting
  • 8 vues
Reasons to choose Dynamics 365 CRM for your business
Reasons to choose Dynamics 365 CRM for your business
  • 11 vues
Medical Device Validation What You Need to Know and Why It is Important
Medical Device Validation What You Need to Know and Why It is Important
  • 12 vues
Lease abstraction can impact the business in strategic ways
Lease abstraction can impact the business in strategic ways
  • 9 vues
What is type 4 DMF?
What is type 4 DMF?
  • 59 vues
Alcohol, Drug Clinical Evaluation
Alcohol, Drug Clinical Evaluation
  • 12 vues
European Union Medical Device Directive (MDD) to Medical Device Regulations (MDR) strategic transition
European Union Medical Device Directive (MDD) to Medical Device Regulations (MDR) strategic transition
  • 28 vues
A Basic Guide to Process Validation in the Pharmaceutical Industry
A Basic Guide to Process Validation in the Pharmaceutical Industry
  • 54 vues
FDA Form 483 Frequently Asked Questions
FDA Form 483 Frequently Asked Questions
  • 23 vues
Process Validation for Medical Devices Overview of FDA Requirements
Process Validation for Medical Devices Overview of FDA Requirements
  • 19 vues
The Clinical Evaluation Report Bringing it Together
The Clinical Evaluation Report Bringing it Together
  • 15 vues
Best Corporate Legal firm in India
Best Corporate Legal firm in India
  • 13 vues
MDR vs. MDD 13 Key Changes
MDR vs. MDD 13 Key Changes
  • 88 vues
USFDA findings of 483 and learning from it
USFDA findings of 483 and learning from it
  • 41 vues
FMEA (Failure Mode Effect Analysis) use in Medical Device industry.
FMEA (Failure Mode Effect Analysis) use in Medical Device industry.
  • 23 vues
Medical Device QMS What It Is, Where It’s Required, and Key Regulations to Know.
Medical Device QMS What It Is, Where It’s Required, and Key Regulations to Know.
  • 14 vues