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How To Prepare for the Transition to ISO 13485:2016

Understanding the Changes to ISO 13485:2016

An Overview of ISO 14971 Risk Management

Insights into the new risk-based changes and specifics on how to comply with the standard.

Everything Device Makers Need to Know About Design Controls

How to Manage & Mitigate Risk in New Product Development

How To Avoid and Respond to FDA 483's and Warning Letters

Clinical Evaluation in the EU for Medical Devices

Medical Device Project Management Best Practices

510(k) Submission Tips, Tricks & Timlines from a Former FDA Reviewer

How to Prepare for the New EU In Vitro Diagnostics Regulations (IVDR)

How to Simplify Your Compliance to the New ISO 13485:2016

How to Prepare for the New EU Medical Device Regulations (MDR)

8 Steps to Implement an EU-MDR Compliance Program

15 Steps to Get Approval to IEC 60601-1

5 Things the Medical Device Industry Should Expect in 2017

What You Need to Know About Life with FDA After Your Device Gains Clearance

Many Connotations of Risk in Medical Device Development

How to Prepare for (and Make the Most of) Your FDA Pre-Submission

How to Prepare for a Successful Design Transfer

How QMS Software Can Speed Up Your Product Development & Simplify Compliance

How to Prepare for the Medical Device Single Audit Program (MDSAP)

Top 10 Most Significant Changes Introduced by the New EU MDR

How to Create a Risk-based CAPA Process

Best Practices for Medical Device Change Management

How Design Controls & Risk Management Best Practices Reduce Customer Complaints & CAPAs