<img src="https://ws.zoominfo.com/pixel/OJkQgdjSvoid2NFoB5Qs" width="1" height="1" style="display: none;">
Products
Guru Difference
Solutions
Customer Experience
Learn
image-mckp (1)-1

Discover the new trends, outlooks, challenges, and opportunities in the MedTech industry in 2023.

Grab a copy
Company
Get a Demo
Get a Demo
Get a Demo

Guest Thought Leadership Articles

Our best MedTech content published in other industry-leading publications.

No results

Thought Leadership Article

Everything You Need to Know about Electronic Data Capture (EDC) Systems

Everything You Need to Know about Electronic Data Capture (EDC) Systems

Learn More
Thought Leadership Article

Three Things MedTech Firms Need to Do for 'True Quality'

By Nick Tippmann Medical Product Outsourcing July 13th, 2022

Learn More
Thought Leadership Article

Top Hiring and Recruiting Tips for Med-Tech Companies

By Nick Tippmann Medical Product Outsourcing July 12th, 2022

Learn More
Thought Leadership Article

True Quality Experts Weigh in on MedTech Future Trends

By Nick Tippmann Medical Product Outsourcing July 8th, 2022

Learn More
Thought Leadership Article

Finding from Greenlight Guru's Benchmark Survey of 519 Medtech Professionals

By Etienne Nichols Project Medtech Podcast June 27th, 2022

Learn More
Thought Leadership Article

Supplier quality management: What medtech manufacturers need to know

By Nick Tippmann Med-Tech Innovation May 17th, 2022

Learn More
Thought Leadership Article

Three Lessons from True Quality 2022

By Nick Tippmann 24x7 Magazine May 17th, 2022

Learn More
Thought Leadership Article

Three Things You Need to Know About FDA QSR and ISO 13485 Harmonization

By Etienne Nichols MedTech Intelligence March 24th, 2022

Learn More
Thought Leadership Article

The End of EUA Is Coming Soon

By Jon Speer Medical Product Outsourcing January 7th, 2022

Learn More
Thought Leadership Article

4 Red Flags Investors Look For When Vetting Your Medical Device Company

By Nick Tippmann MedTech Intelligence November 22nd, 2021

Learn More
Thought Leadership Article

Risk Management for Medical Devices

By Wade Schroeder Quality Digest September 2nd, 2021

Learn More
Thought Leadership Article

EU MDR Preparedness: How Is COVID-19 a Factor?

By Jon Speer Medical Product Outsourcing July 6th, 2021

Learn More
Thought Leadership Article

How an MDQMS Can Lead to More Efficient and Sustainable Diagnostic Tests

By Brandon Henning Medical Product Outsourcing July 1st, 2021

Learn More
Thought Leadership Article

Closed-Loop Traceability for FDA Compliance

By Jon Speer Quality Digest, June 2nd, 2021

Learn More
Thought Leadership Article

Preparing for the EU’s MDR

By Nick Tippmann Medical Product Outsourcing, April 29th, 2021

Learn More
Thought Leadership Article

What Are the Biggest Changes under EU MDR?

By Jon Speer MedTech Intelligence, April 14th, 2021

Learn More
Thought Leadership Article

Using Quality as an Advantage in 2021

By Jon Speer Medical Product Outsourcing, March 25th, 2021

Learn More
Thought Leadership Article

Three Reasons Automation and Training Are Essential in Your MDQMS

By Jon Speer Medical Product Outsourcing, March 15th, 2021

Learn More
Thought Leadership Article

What Is Quality Culture and Does Your Company Have It?

By Jon Speer Medical Device and Diagnostic Industry, March 15th, 2021

Learn More
Thought Leadership Article

Why You Must Have a Single Source of Truth for CAPA

By Jon Speer MedTech Intelligence, December 15th, 2020

Learn More
Thought Leadership Article

Expert Roundup: Achieving Success in the 2021 Medical Device Landscape

By Nick Tippmann Medical Product Outsourcing, December 4th, 2020

Learn More
Thought Leadership Article

Imagine It’s 2030: What Was the Key To Business Success During COVID-19?

By David DeRam Inside INdiana Business, December 3rd, 2020

Learn More
Thought Leadership Article

Traceability Requirements in EU MDR

By Jon Speer Medical Device and Diagnostic Industry (MD+DI), November 12th, 2020

Learn More
Thought Leadership Article

Four Essential Processes in Medical Device Risk Management

By Jon Speer Quality Digest, September 29th, 2020

Learn More
Thought Leadership Article

Adopting a Data-Driven Approach to Quality with an MDQMS

By Jon Speer Medical Product Outsourcing, September 24th, 2020

Learn More
Thought Leadership Article

The Importance of Managing and Controlling Risk in the Medical Device Industry

By Jon Speer Quality Digest, September 8th, 2020

Learn More
Thought Leadership Article

Why I Left a MedTech Manufacturer For a Software Scale-Up

By Wade Schroeder Inside INdiana Business, August 6th, 2020

Learn More
Thought Leadership Article

Areas to Consider in Medical Device Risk Management

By Jon Speer Medical Product Outsourcing, August 24th, 2020

Learn More
Thought Leadership Article

Ensure Success Throughout the Entire Medical Device Lifecycle

By Jon Speer Medical Device and Diagnostics Industry, August 4th, 2020

Learn More
Thought Leadership Article

What Consumer Tech Companies Need To Know About Medical Devices In The European Union

By David DeRam Forbes, July 30th, 2020

Learn More
Thought Leadership Article

From the Experts: Best Practices to Ensure Device Success

By Jon Speer Medical Product Outsourcing, July 27th, 2020

Learn More
Thought Leadership Article

Best Practices for Leading Medical Device Teams During the COVID-19 Pandemic

By Jon Speer MedTech Intelligence, June 24th, 2020

Learn More
Thought Leadership Article

Managing and Leading Medical Device Companies and Teams During the Pandemic

By Jon Speer Medical Product Outsourcing, May 28th, 2020

Learn More
Thought Leadership Article

COVID-19’s Impact on the MedTech Industry: How to Get Through

By Jon Speer MedTech Intelligence, May 19th, 2020

Learn More
Thought Leadership Article

What You Need to Know for an Effective Risk Assessment

By Jon Speer Quality Digest, May 14th, 2020

Learn More
Thought Leadership Article

What Consumer Tech Companies Need To Know About Medical Devices In The US

By David DeRam Forbes, May 8th, 2020

Learn More
Thought Leadership Article

Engineers: How to Curb Quality Myths Now

By Jon Speer MedTech Intelligence, April 27th, 2020

Learn More
Thought Leadership Article

Building a Medtech Firm on a Foundation of Quality

By Nick Tippmann Medical Product Outsourcing, April 6th, 2020

Learn More
Thought Leadership Article

Paper Processes: Three Reasons It’s a Costly Business Move

By Jon Speer MedTech Intelligence, March 6th, 2020

Learn More
Thought Leadership Article

Paper Is Expensive

By Jon Speer Quality Digest, February 17th, 2020

Learn More
Thought Leadership Article

The True Cost of Paper

By Jon Speer Medical Product Outsourcing, February 13th, 2020

Learn More
Thought Leadership Article

4 Powerful Ways Mindfulness Encourages Peak Performance

By David DeRam Forbes, February 4th, 2020

Learn More
Thought Leadership Article

Why Great Companies Don't Run On Spreadsheets

By David DeRam Forbes, February 3rd, 2020

Learn More
Thought Leadership Article

3 Keys to Attracting Investors and Raising Funds for Your Med Device

By Jon Speer Healthcare Business Today, January 20th, 2020

Learn More
Thought Leadership Article

Six Mistakes to Avoid When Implementing ISO 13485

By Jon Speer Medical Product Outsourcing, January 20th, 2020

Learn More
Thought Leadership Article

5 Tips To Raise Funding For Your Medical Device

By Jon Speer Medical Design & Outsourcing, January 16th, 2020

Learn More
Thought Leadership Article

5 Tips to Raise Investor Interest and Fund Your Medical Device

By Jon Speer Medical Product Outsourcing, January 15th, 2020

Learn More
Thought Leadership Article

4 Keys to Funding Your Medical Device

By Jon Speer MedTech Intelligence, December 27th, 2019

Learn More
Thought Leadership Article

We’re going through changes: Major upcoming regulatory changes for manufacturers explained

By Jon Speer Medical Plastics News, November 11th, 2019

Learn More
Thought Leadership Article

Top 3 Mistakes You Can Make When Adopting ISO 13485

By Jon Speer Medtech Intelligence, November 8th, 2019

Learn More
Thought Leadership Article

A Tsunami of Regulatory Changes is Coming

By Jon Speer In Compliance, October 31st, 2019

Learn More
Thought Leadership Article

Top 4 Mistakes When Implementing ISO 13485

By Jon Speer Medical Design & Outsourcing, October 30th, 2019

Learn More
Thought Leadership Article

Five Tips From Medtech Executives on the Value of Quality

By Jon Speer Quality Digest, October 22nd, 2019

Learn More
Thought Leadership Article

The Essential Guide To Preparing Your QMS For EU MDR

By Jon Speer The MedTech Conference , August 26th, 2019 How prepared is your quality management system for the new requirements of EU MDR for medical devices that ...

Learn More
Thought Leadership Article

Not All Medical Device QMS Solutions Are Created Equal

By Evan Luxon, Centese (Greenlight Guru customer), Medical Product Outsourcing, June 24th, 2019. As an early-stage medical device company, it may seem simpler to ...

Learn More
Thought Leadership Article

Quality Is The Heartbeat Of Your Company

By David Deram, Forbes, June 13th, 2019. Quality is manifested by the level of commitment that’s invested. Quality outcomes don’t happen by chance; they are ...

Learn More
Thought Leadership Article

Qualifying Your Suppliers Using a Risk-Based Approach

By Jon Speer Quality Digest, June 13th, 2019

Learn More
Thought Leadership Article

Choosing The Right QMS For Your Medical Device Company

By Evan Luxon, Centese (Greenlight Guru customer) MedTech Intelligence, May 14th, 2019

Learn More
Thought Leadership Article

The Most Common Problems With Your CAPA Process

By Jon Speer ECN, March 25th, 2019

Learn More
Thought Leadership Article

What To Expect During an FDA QSIT Inspection

By Jon Speer Quality Digest, March 19th, 2019

Learn More
Thought Leadership Article

Top 26 Medical Device Conferences To Attend in 2019

By Jon Speer ECN Magazine, February 14th, 2019

Learn More
Thought Leadership Article

Creating an It Factor Culture

By David Deram The Sales Evangelist, December 7th, 2018

Learn More
Thought Leadership Article

2019 MedTech Predictions

By Jon Speer MedTech Intelligence, December 3rd, 2018

Learn More
Thought Leadership Article

6 Best Practices for Complying with ISO 13485:2016

By Jon Speer Medical Product Outsourcing, October 17th, 2018

Learn More
Thought Leadership Article

Why Paper-Based Systems No Longer Make the Cut

By David DeRam MedTech Intelligence, October 8th, 2018

Learn More
Thought Leadership Article

5 Tips for Post-Market Medical Device Compliance

By Jon Speer Medical Design & Outsourcing, September 24th, 2018

Learn More
Thought Leadership Article

Why Cloud Software Companies Should Build for Vertical Industries

By David DeRam DZone, August 21st, 2018

Learn More
Thought Leadership Article

5 Reasons Design Controls and Risk Management Processes Fail

By Jon Speer Medical Product Outsourcing, August 20th, 2018

Learn More
Thought Leadership Article

Cloud Companies Should Build for Vertical Industries

By David DeRam InformationWeek August 13th, 2018

Learn More
Thought Leadership Article

How to Avoid a Medtech Document Scavenger Hunt

By Jon Speer MedCity News August 8th, 2018

Learn More
Thought Leadership Article

Five Common Mistakes Companies Make With CAPA

By Jon Speer Quality Digest June 20th, 2018

Learn More
Thought Leadership Article

Why the FDA Presubmission Is an Underutilized Tool

By Jon Speer Quality Digest April 30th, 2018

Learn More
Thought Leadership Article

A timeline to adopt medical device QMS (and why you need to act now)

By Jon Speer MedCity News April, 23rd 2018

Learn More
Thought Leadership Article

How To Structure Your Internal Audit Program

By Jon Speer Med Device Online April 2nd, 2018

Learn More
Thought Leadership Article

Here’s what you need to know about FDA’s new guidance on software as a medical device

By Jon Speer MedCity News March 29th, 2018

Learn More
Thought Leadership Article

Elite Sports Teams Are Much Better at Creating Powerful Cultures Than Startups — Here Are 5 Tips You Can Steal

By David DeRam Business 2 Community March 15th, 2018

Learn More
Thought Leadership Article

How to streamline the customer complaint handling process

By Jon Speer Medical Design & Outsourcing February 9th, 2018

Learn More
Thought Leadership Article

The Impact of Risk Management on CAPA

By Jon Speer Medical Device and Diagnostics Industry February 8th, 2018

Learn More
Thought Leadership Article

The Countdown to Implementing ISO 13485:2016

By Jon Speer Medical Device and Diagnostics Industry January 31st, 2018

Learn More
Thought Leadership Article

Greenlight Guru Revenue Rockets In Q4, Plans Hiring Spree In Q1

By Greenlight Guru Med Device Online January 30th, 2018

Learn More
Thought Leadership Article

How to Integrate Complaint Handling and Risk Management

By Jon Speer Quality Digest January 30th, 2018

Learn More
Thought Leadership Article

5 things to address if you’re a medical device startup

By Jon Speer Med-Tech Inovation January 30th, 2018

Learn More
Thought Leadership Article

What should really trigger a CAPA?

By Jon Speer Medical Design & Outsourcing January 23rd, 2018

Learn More
Thought Leadership Article

Why the best engineers are attracted to big problems

By David Odmark Techpoint January 16th, 2018

Learn More
Thought Leadership Article

5 predictions for the medical device industry in 2018 (and how you can prepare)

By Jon Speer MedCity News January 16th, 2018

Learn More
Thought Leadership Article

The potential impact of FDA’s use of PRO to assess effects of medical devices

By Jon Speer MedCity News December 21st, 2017

Learn More
Thought Leadership Article

How CAPA Connects to Other QMS Processes

By Jon Speer Quality Digest December 19th, 2017

Learn More
Thought Leadership Article

What a Risk-Based QMS Means

By Jon Speer Quality Digest November 27th, 2017

Learn More
Thought Leadership Article

5 Tips for Medical Device Engineers on FDA Design Controls

By Jon Speer Diagnostic and Interventional Cardiology November 24th, 2017

Learn More
Thought Leadership Article

The 5 Most Common Problems With Your CAPA Process

By Jon Speer Med Device Online November 17th, 2017

Learn More
Thought Leadership Article

Design History File vs. 510(k) vs. Technical File: What Do Medical Device Developers Need to Know?

By Jon Speer Medical Device and Diagnostics Industry November 16th, 2017

Learn More
Thought Leadership Article

Design Validation vs. Clinical Evaluation: What's the difference?

By Jon Speer Quality Digest October 17th, 2017

Learn More
Thought Leadership Article

How to prepare your medical device company for an FDA inspection

By Jon Speer MedCity News October 17th, 2017

Learn More
Thought Leadership Article

How to define and decode your design inputs and design outputs

By Jon Speer Mass Device October 5th, 2017

Learn More
Thought Leadership Article

How to define and decode your design inputs and design outputs

By Jon Speer Medical Design & Outsourcing October 5th, 2017

Learn More
Thought Leadership Article

7 Common Mistakes That Sink FDA 510(k) Clearance

By Jon Speer Med Device Online October 2nd, 2017

Learn More
Thought Leadership Article

Elite Sports Teams Are Much Better at Creating Powerful Cultures Than Startups -- Here Are 5 Tips You Can Steal

By David DeRam Entrepreneur September 27th, 2017

Learn More
Thought Leadership Article

How to Debunk the Most Common CAPA Myths

By Jon Speer The MedTech Conference September 21st, 2017

Learn More
Thought Leadership Article

Proper Design Controls Could Save You $20 Million

By Jon Speer Medical Product Outsourcing September 7th, 2017

Learn More
Thought Leadership Article

Why Your Medical Device QMS Should Match the Size of Your Company

By Jon Speer Quality Digest August 19th, 2017

Learn More
Thought Leadership Article

15 Startup Secrets You Can Steal From Sports Cultures

By David DeRam Powderkeg August 24th, 2017

Learn More
Thought Leadership Article

How to Prepare Your Design History File For An FDA Inspection

By Jon Speer Med Device Online August 22nd, 2017

Learn More
Thought Leadership Article

Debunking 8 commonly held CAPA myths

By Jon Speer MedCity News August 21st, 2017

Learn More
Thought Leadership Article

Medical device product development: pitfalls you need to avoid

By John Speer MassDevice August 18th, 2017

Learn More
Thought Leadership Article

Medical device product development: 7 pitfalls you need to avoid

By Jon Speer Medical Design & Outsourcing August 18th, 2017

Learn More
Thought Leadership Article

Four Ways to Build an Elite Team (On or Off The Field)

By David DeRam Inside INdiana Business August 16th, 2017

Learn More
Thought Leadership Article

What are the best ways to handle medical device customer complaints?

By Jon Speer MedCity News June 15th, 2017

Learn More
Thought Leadership Article

What should trigger a CAPA in medical device manufacturing?

By Jon Speer MedCity News May 25th, 2017

Learn More
Thought Leadership Article

Correcting misconceptions about FDA design controls for the medical device industry

By Jon Speer MedCity News May 15th, 2017

Learn More
Thought Leadership Article

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

By John Speer Medical Device and Diagnostic Industry April 25th, 2017

Learn More
Thought Leadership Article

4 key compliance issues for medical device companies

By Jon Speer MedCity News April 13th, 2017

Learn More
Thought Leadership Article

Five Tips for Medical Device Engineers on FDA Design Controls

By Jon Speer Quality Digest March 28th, 2017

Learn More
Thought Leadership Article

5 predictions for the medical device industry

By Jon Speer MedCity News March 3rd, 2017

Learn More
Thought Leadership Article

Key Challenges for Risk Management in Medical Device Development

By Jon Speer Quality Digest February 13th, 2017

Learn More
Thought Leadership Article

3 tips for managing your medical device design history file

By Jon Speer MedCity News October 16th, 2016

Learn More
Thought Leadership Article

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

By Jesseca Lyons Med Device Online September 19th, 2016

Learn More
Thought Leadership Article

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

By Jesseca Lyons Medical Product Outsourcing Jesseca Lyons on September 15th, 2016

Learn More
Thought Leadership Article

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

By Jon Speer Quality Digest August 23rd, 2016

Learn More
Thought Leadership Article

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

By Jon Speer MedCity News August 18th, 2016

Learn More
Thought Leadership Article

4 Tips for a Smooth 510(k) Submission Process

By Jon Speer Medical Device and Diagnostics Industry August 17th, 2016

Learn More
Thought Leadership Article

ISO 14971 or FMEA: Which Should You Use?

By Jesseca Lyons Quality Digest August 9th, 2016

Learn More
Thought Leadership Article

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

By Jon Speer Med Device Online July 27th, 2016

Learn More
Thought Leadership Article

Debunking 4 commonly held design control myths

By Jon Speer MedCity News July 25th, 2016

Learn More
Thought Leadership Article

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

By Jon Speer MedCity News July 14th, 2016

Learn More
Thought Leadership Article

Eight Reasons Why Your Design Controls and Risk Management Processes Fail

By Jon Speer Quality Digest July 5th, 2016

Learn More
Thought Leadership Article

Understanding ISO 14971 medical device risk management

By Jon Speer MedCity News June 6th, 2016

Learn More
Thought Leadership Article

3 tips for applying risk management across medical device product development

By Jon Speer MedCity News May 26th, 2016

Learn More
Thought Leadership Article

The Definitive Guide to Responding to FDA 483 and Warning Letters

By Jon Speer Medical Design Technology May 19th, 2016

Learn More
Thought Leadership Article

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

By Jon Speer MedCity News May 19th, 2016

Learn More
Thought Leadership Article

8 Reasons Design Controls And Risk Management Processes Fail

By Jon Speer Med Device Online May 19th, 2016

Learn More
Thought Leadership Article

How design controls apply to a 510(k)

By Jon Speer MedCity News May 5th, 2016

Learn More
Thought Leadership Article

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

Inspired Imua Podcast April 21st, 2016

Learn More
Thought Leadership Article

Why FMEA Is Not ISO 14971

By Jon Speer Quality Digest April 20th, 2016

Learn More
Thought Leadership Article

Are Design Control Myths Holding Back Your Product Development?

By Jon Speer Med Device Online April 1st, 2016

Learn More
Thought Leadership Article

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

By Jon Speer Medical Design Technology March 9th, 2016

Learn More
Thought Leadership Article

MedTech Blunders in Risk Management

By Jon Speer MedTech Intelligence March 4th, 2016

Learn More
Thought Leadership Article

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

By Jon Speer MedCity News March 1st, 2016

Learn More
Thought Leadership Article

Risk: Look at the Big Picture

By Jon Speer MedTech Intelligence February 15th, 2016

Learn More
Thought Leadership Article

How to Prepare for an FDA Inspection

By Jon Speer Quality Digest February 8th, 2016

Learn More
Thought Leadership Article

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

By Jon Speer Med Device Online February 5th, 2016

Learn More
Thought Leadership Article

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

By Jon Speer Med Device Online January 10th, 2016

Learn More
Thought Leadership Article

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

By Jon Speer MedCity News December 16th, 2015

Learn More
Thought Leadership Article

7 Steps to Respond to FDA 483 Inspection Observations

By Jon Speer MedTech Intelligence November 12th, 2015

Learn More
Thought Leadership Article

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

By Jon Speer Med Device Online November 16th, 2015

Learn More
Thought Leadership Article

The Importance of the Risk Management Plan

By Jon Speer Medical Design Technology November 10th, 2015

Learn More
Thought Leadership Article

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

By Jon Speer MedCity News November 9th, 2015

Learn More
Thought Leadership Article

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

By Jon Speer Legacy MEDSearch November 6th, 2015

Learn More
Thought Leadership Article

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

By Jon Speer Qmed November 5th, 2015

Learn More
Thought Leadership Article

Risk management definitions you need to understand

By Jon Speer Mass Device November 5th, 2015

Learn More
Thought Leadership Article

The beginner's guide to MedTech design verification and validation

By Jon Speer MedCity News October 30th, 2015

Learn More
Thought Leadership Article

How to Avoid Exponentially Escalating Costs with Design Controls

By Jon Speer Qmed October 28th, 2015

Learn More
Thought Leadership Article

3 Tips for Incorporating Risk Management Throughout Medical Device Product Development

By Jon Speer Medical Design Technology October 20th, 2015

Learn More
Thought Leadership Article

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

By Jon Speer Med Device Online October 19th, 2015

Learn More
Thought Leadership Article

5 tips to help you prepare for an FDA inspection

By Jon Speer MedCity News October 13th, 2015

Learn More
Thought Leadership Article

4 Reasons Your Risk Management Approach is Wrong

By Jon Speer MedTech Intelligence September 28th, 2015

Learn More
Thought Leadership Article

How to make FDA work for you – ATL Device Night

By Nick Tippmann Mass Device September 25th, 2015

Learn More
Thought Leadership Article

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

By Jon Speer MedCity News September 23rd, 2015

Learn More
Thought Leadership Article

5 Tips For Better Medical Device Risk Management

By Jon Speer Med Device Online September 15th, 2015

Learn More
Thought Leadership Article

How to define medical device design inputs and outputs

By Jon Speer MedCity News September 15th, 2015

Learn More
Thought Leadership Article

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

By Jon Speer Medical Design Technology September 15th, 2015

Learn More
Thought Leadership Article

How medical device complaints can make you a better company

By Jon Speer MedCity News September 10th, 2015

Learn More
Thought Leadership Article

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

By Jon Speer OrthoStreams September 3rd, 2015

Learn More
Thought Leadership Article

How to improve your medical device startup’s funding chances

By Jon Speer MedCity News September 1st, 2015

Learn More
Thought Leadership Article

Stop Treating Risk Management & Design Controls As Checkbox Activities

By Jon Speer Med Device Online September 1st, 2015

Learn More
Thought Leadership Article

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

By Jon Speer MedCity News August 19th, 2015

Learn More
Thought Leadership Article

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

By Jon Speer MedCity News August 12th, 2015

Learn More
Thought Leadership Article

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

By Jon Speer MedCity News August 5th, 2015

Learn More
Thought Leadership Article

Are We in the Golden Age of Medical Devices?

By Jon Speer Medical Design Technology July 29th, 2015

Learn More
Thought Leadership Article

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

By Jon Speer Med Device Online July 16th, 2015

Learn More
Thought Leadership Article

Top Three Document Management Tips for Medical Device Companies

By Jon Speer Quality Digest Jon Speer & Alex Morris on July 8th, 2015

Learn More
Thought Leadership Article

3 steps to getting your medical device startup off the ground

By Jon Speer MedCity News July 1st, 2015

Learn More
Thought Leadership Article

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

By Jon Speer MedCity News June 22nd, 2015

Learn More
Thought Leadership Article

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

By Jon Speer MedCity News June 8th, 2015

Learn More
Thought Leadership Article

The Medtech Adventures of Eddy the Engineer

By Jon Speer Qmed June 2nd, 2015

Learn More
Thought Leadership Article

15 items medical device startups need to address

By Jon Speer MedCity News May 27th, 2015

Learn More
Thought Leadership Article

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

By Jon Speer MedCity News May 13th, 2015

Learn More
Thought Leadership Article

4 medical device quality system musts for startups

By Jon Speer MedCity News April 30th, 2015

Learn More
Thought Leadership Article

The Art Of Medical Device Design Inputs

Med Device Online April 27th, 2015

Learn More
Thought Leadership Article

Eight Questions That Define Your Medical Device User Needs

By Jon Speer Quality Digest April 21st, 2015

Learn More
Thought Leadership Article

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

By Jon Speer MedCity News April 16th, 2015

Learn More
Thought Leadership Article

Your 5 Step Blueprint for Great MedTech Design Reviews

By Jon Speer Qmed April 9th, 2015

Learn More
Thought Leadership Article

How to run effective medical device design reviews

By Jon Speer MedCity News April 9th, 2015

Learn More
Thought Leadership Article

3 Tips for Managing Your Medical Device Design History File

By Jon Speer Medical Design Technology March 31st, 2015

Learn More
Thought Leadership Article

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

By Jon Speer MedCity News March 30th, 2015

Learn More
Thought Leadership Article

How Medtech Startups Can Navigate Design Controls

By Jon Speer Qmed March 12th, 2015

Learn More