Все публикации

1:30:28

Post-Market Surveillance for Medical Devices & Combination Products

1:15:21

How to Implement and Maintain a Modern CAPA System while Avoiding Common Pitfalls

1:29:31

Refuse to Accept & Additional Information Request: Avoiding Problems with Medical Device Submissions

0:56:02

Demystifying FDA’s Pre-Market Final Guidance

1:28:05

Beyond Design Controls 101: Following the Regulation vs. Understanding its Intent

1:05:23

10 Things You Must Know About Updating Your Technical Files to Comply with EU MDR

1:31:15

Change Management and Risk Management: How Do We Connect the Dots and What Happens if We Don’t?

1:20:22

Bridging the Gap Between Development and Regulatory Teams

1:05:20

How to Apply Risk Management Throughout the Product Lifecycle of Your Medical Device

1:20:11

Preparing Your Technical Documentation under MDR: Proven Tips & Techniques

0:44:58

Developing IEC 62304 Compliant Software: Proven Tips & Best Practices

1:15:30

How to Survive an FDA Inspection

0:59:37

Alternatives to PMCF Clinical Investigations

1:30:26

Understanding the Medical Device Classification System

1:30:12

Letter to File 101: Are You Sure You're Preparing Yours Correctly?

1:31:24

Usability Testing: Why Can’t We Get It Right?

1:08:14

How and When to Register EU Medical Devices and Report UDI Information to EUDAMED

0:58:05

When Design Input Requirements Go Wrong

0:59:23

Prepping your QMS for EU MDR

1:18:37

How to Use Clinical Data for Medical Device Submissions in both EU & US

1:27:35

Evaluating the Need for Biocompatibility Testing & Mitigating Risks when Changing a Medical Device

1:23:14

How to Create Your DHF/TF & RMF for a Hardware or Software Medical Device

1:29:01

Human Factors Engineering: The Worldwide Guide for Medical Device Manufacturers

0:44:08

Demonstrating Conformity to General Safety and Performance Requirements GSPR under MDR