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FDA's Case for Quality: Simplifying the regulatory activities (Part 4 of 4)

Quality VS Compliance Metrics & What's Next for FDA's Case for Quality Pilot (Part 3 of 4)

The Pre-Market Approval (PMA): Is it really as bad as so many think?

FDA's Case for Quality: Voluntary Program and Status Update (Part 2 of 4)

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

FDA's Case for Quality: What, Why and How? Changing the Regulatory Paradigm

Greenlight Guru has partnered with FDA to give you the inside track on what you need to know about the Case for Quality, the changing regulatory paradigm, and what all this means for all stakeholders involved with the medical device industry.

Bridging User Needs & Design Requirements

A Timeline to Comply with ISO 13485:2016 (And What You Need to Be Doing Today)

General Wellness Devices & Wearables: Regulatory Options You Need to Know

5 Predictions for the Medical Device Industry in 2018 (And How You Can Prepare)

Regulatory Intelligence (Mis)Management in the Medical Device Industry

How Software Can Be Leveraged to Streamline Device Development

Demystifying the FDA's Human Factors Guidance

What You Need to Know About Medical Electrical Standards Updates

Advanced Strategies and Tactics for Using the De Novo Pathway

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

Best Practices for Medical Device Change Management

How to Create a Risk-based CAPA Process

Top 10 Most Significant Changes Introduced by the New EU MDR

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

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

Learn how modern, purpose-built software not only ensures you compliance with all the latest regulations but also frees up your engineers’ time, reduces risk, speeds time to market, and help you pass audits with flying colors.

How to Prepare for a Successful Design Transfer

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

Many Connotations of Risk in Medical Device Development

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

5 Things the Medical Device Industry Should Expect in 2017

15 Steps to Get Approval to IEC 60601-1

8 Steps to Implement an EU-MDR Compliance Program

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

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

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

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

Medical Device Project Management Best Practices

Clinical Evaluation in the EU for Medical Devices

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

Everything Device Makers Need to Know About Design Controls

An Overview of ISO 14971 Risk Management

Understanding the Changes to ISO 13485:2016

How To Prepare for the Transition to ISO 13485:2016

How to Manage & Mitigate Risk in New Product Development