Guest Thought Leadership Articles | greenlight.guru

Why You Must Know the Difference Between 'Intended Use' and 'Indications for Use'

4 key compliance issues for medical device companies

Five Tips for Medical Device Engineers on FDA Design Controls

5 predictions for the medical device industry

Key Challenges for Risk Management in Medical Device Development

3 tips for managing your medical device design history file

4 Reasons Your 510(k) Submission Will Be Rejected (And How To Avoid Them)

3 Tips to Reduce the Chance of a 510(k) Submission Rejection

Six Tips to Make Sure Your 510(k) Submission Is Accepted

6 tips to reduce likelihood of a rejection for an FDA 510(k) submission

4 Tips for a Smooth 510(k) Submission Process

ISO 14971 or FMEA: Which Should You Use?

First-In-Human Studies - What's The Rush?

Debunking 4 commonly held design control myths

Navigating the difficult road of medical device product development while avoiding the common pitfalls

Eight Reasons Why Your Design Controls and Risk Management Processes Fail

Understanding ISO 14971 medical device risk management

3 tips for applying risk management across medical device product development

The Definitive Guide to Responding to FDA 483 and Warning Letters

What were the top reasons FDA issued device makers 483’s and warning letters in 2015

8 Reasons Design Controls And Risk Management Processes Fail

How design controls apply to a 510(k)

Get and stay on the FDA's good side with Jon Speer

Why FMEA Is Not ISO 14971

Are Design Control Myths Holding Back Your Product Development?

A Step-by-Step Guide to Complying with Medical Device QMS Requirements

MedTech Blunders in Risk Management

5 Tips to Help Your FDA 510(k) Submission (checklist included)

Risk: Look at the Big Picture

How to Prepare for an FDA Inspection

6 Development Steps To Fast-Track Your Medical Device's Path To Market

The Design Controls + Risk Management Connection — Using Design Reviews Effectively

An alarming device trend: Why getting 510(k) clearance alone is not enough

7 Steps to Respond to FDA 483 Inspection Observations

The Design Controls + Risk Management Connection — Verification, Validation & Risk Controls

The Importance of the Risk Management Plan

Design Controls & Risk Management: Two Sides of the Same Coin [Infographic]

Risk Management: A Total Product Life-cycle Process [Infographic]

Risk Management for Medical Devices: An Introduction to the Process [Infographic]

Risk management definitions you need to understand

The beginner’s guide to MedTech design verification and validation

How to Avoid Exponentially Escalating Costs with Design Controls

3 Tips for Incorporating Risk Management Throughout Medical Device Product Development

The Design Controls + Risk Management Connection — Intended Use & User Needs

5 tips to help you prepare for an FDA inspection

4 Reasons Your Risk Management Approach is Wrong

How to make FDA work for you – ATL Device Night

The $400,000 FDA compliance mistake you don’t want to make

5 Tips For Better Medical Device Risk Management

How to define medical device design inputs and outputs

The Beginner's Guide to ISO 14971 Medical Device Risk Management

How medical device complaints can make you a better company

Case Study: 5 Mistakes that lead to flushing $400,000 in fighting the FDA

How to improve your medical device startup’s funding chances

Stop Treating Risk Management & Design Controls As Checkbox Activities

Three ways to determine whether your medical device company suffers from disconnect

Is your risk management system for medical devices up to date?

What’s the best approach to medical device Design Reviews?

Are We in the Golden Age of Medical Devices?

5 Tips To Help Your FDA 510(k) Submission (Checklist Included)

Top Three Document Management Tips for Medical Device Companies

3 steps to getting your medical device startup off the ground

Regulatory classification 101: A guide to how your medical device will be classified

What issues draw the most attention in FDA medical device inspections?

The Medtech Adventures of Eddy the Engineer

15 items medical device startups need to address

Why medical device startups need to master juggling and balancing with focus

4 medical device quality system musts for startups

The Art Of Medical Device Design Inputs

Eight Questions That Define Your Medical Device User Needs

2 things you should do asap when starting a medical device project

Your 5 Step Blueprint for Great MedTech Design Reviews

How to run effective medical device design reviews

3 Tips for Managing Your Medical Device Design History File

From Idea to Market Release: Your Quick Guide to FDA Design Controls

How Medtech Startups Can Navigate Design Controls