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Five Common Mistakes Companies Make With CAPA

Five Common Mistakes Companies Make With CAPA

By Jon Speer

Quality Digest June 20th, 2018

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Why the FDA Presubmission Is an Underutilized Tool

Why the FDA Presubmission Is an Underutilized Tool

By Jon Speer

Quality Digest April 30th, 2018

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

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

By Jon Speer

MedCity News April, 23rd 2018

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How To Structure Your Internal Audit Program

How To Structure Your Internal Audit Program

By Jon Speer

Med Device Online April 2nd, 2018

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

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

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

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

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How to streamline the customer complaint handling process

How to streamline the customer complaint handling process

By Jon Speer

Medical Design & Outsourcing February 9th, 2018

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The Impact of Risk Management on CAPA

The Impact of Risk Management on CAPA

By Jon Speer

Medical Device and Diagnostics Industry February 8th, 2018

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The Countdown to Implementing ISO 13485:2016

The Countdown to Implementing ISO 13485:2016

By Jon Speer

Medical Device and Diagnostics Industry January 31st, 2018

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

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

By Greenlight Guru

Med Device Online January 30th, 2018

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How to Integrate Complaint Handling and Risk Management

How to Integrate Complaint Handling and Risk Management

By Jon Speer

Quality Digest January 30th, 2018

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

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

By Jon Speer

Med-Tech Inovation January 30th, 2018

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What should really trigger a CAPA?

What should really trigger a CAPA?

By Jon Speer

Medical Design & Outsourcing January 23rd, 2018

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Why the best engineers are attracted to big problems

Why the best engineers are attracted to big problems

By David Odmark

Techpoint January 16th, 2018

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

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

By Jon Speer

MedCity News January 16th, 2018

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

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

By Jon Speer

MedCity News December 21st, 2017

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How CAPA Connects to Other QMS Processes

How CAPA Connects to Other QMS Processes

By Jon Speer

Quality Digest December 19th, 2017

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What a Risk-Based QMS Means

What a Risk-Based QMS Means

By Jon Speer

Quality Digest November 27th, 2017

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5 Tips for Medical Device Engineers on FDA Design Controls

5 Tips for Medical Device Engineers on FDA Design Controls

By Jon Speer

Diagnostic and Interventional Cardiology November 24th, 2017

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The 5 Most Common Problems With Your CAPA Process

The 5 Most Common Problems With Your CAPA Process

By Jon Speer

Med Device Online November 17th, 2017

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

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

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

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

By Jon Speer

Quality Digest October 17th, 2017

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How to prepare your medical device company for an FDA inspection

How to prepare your medical device company for an FDA inspection

By Jon Speer

MedCity News October 17th, 2017

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How to define and decode your design inputs and design outputs

How to define and decode your design inputs and design outputs

By Jon Speer

Mass Device October 5th, 2017

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How to define and decode your design inputs and design outputs

How to define and decode your design inputs and design outputs

By Jon Speer

Medical Design & Outsourcing October 5th, 2017

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7 Common Mistakes That Sink FDA 510(k) Clearance

7 Common Mistakes That Sink FDA 510(k) Clearance

By Jon Speer

Med Device Online October 2nd, 2017

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

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

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How to Debunk the Most Common CAPA Myths

How to Debunk the Most Common CAPA Myths

By Jon Speer

The MedTech Conference September 21st, 2017

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Proper Design Controls Could Save You $20 Million

Proper Design Controls Could Save You $20 Million

By Jon Speer

Medical Product Outsourcing September 7th, 2017

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

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

By Jon Speer

Quality Digest August 19th, 2017

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15 Startup Secrets You Can Steal From Sports Cultures

15 Startup Secrets You Can Steal From Sports Cultures

By David DeRam

Powderkeg August 24th, 2017

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How to Prepare Your Design History File For An FDA Inspection

How to Prepare Your Design History File For An FDA Inspection

By Jon Speer

Med Device Online August 22nd, 2017

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Debunking 8 commonly held CAPA myths

Debunking 8 commonly held CAPA myths

By Jon Speer

MedCity News August 21st, 2017

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Medical device product development: pitfalls you need to avoid

Medical device product development: pitfalls you need to avoid

By John Speer

MassDevice August 18th, 2017

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Medical device product development: 7 pitfalls you need to avoid

Medical device product development: 7 pitfalls you need to avoid

By Jon Speer

Medical Design & Outsourcing August 18th, 2017

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

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

By David DeRam

Inside INdiana Business August 16th, 2017

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

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

By Jon Speer

MedCity News June 15th, 2017

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What should trigger a CAPA in medical device manufacturing?

What should trigger a CAPA in medical device manufacturing?

By Jon Speer

MedCity News May 25th, 2017

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Correcting misconceptions about FDA design controls for the medical device industry

Correcting misconceptions about FDA design controls for the medical device industry

By Jon Speer

MedCity News May 15th, 2017

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

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

By John Speer

Medical Device and Diagnostic Industry April 25th, 2017

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4 key compliance issues for medical device companies

4 key compliance issues for medical device companies

By Jon Speer

MedCity News April 13th, 2017

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Five Tips for Medical Device Engineers on FDA Design Controls

Five Tips for Medical Device Engineers on FDA Design Controls

By Jon Speer
Quality Digest March 28th, 2017
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5 predictions for the medical device industry

5 predictions for the medical device industry

By Jon Speer
MedCity News March 3rd, 2017
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Key Challenges for Risk Management in Medical Device Development

Key Challenges for Risk Management in Medical Device Development

By Jon Speer
Quality Digest February 13th, 2017
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3 tips for managing your medical device design history file

3 tips for managing your medical device design history file

By Jon Speer
MedCity News October 16th, 2016
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4 Reasons Your 510(k) Submission Will Be Rejected (And How To Avoid Them)

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

By Jesseca Lyons
Med Device Online September 19th, 2016
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3 Tips to Reduce the Chance of a 510(k) Submission Rejection

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

By Jesseca Lyons
Medical Product Outsourcing Jesseca Lyons on September 15th, 2016
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Six Tips to Make Sure Your 510(k) Submission Is Accepted

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

By Jon Speer
Quality Digest August 23rd, 2016
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6 tips to reduce likelihood of a rejection for an FDA 510(k) submission

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

By Jon Speer
MedCity News August 18th, 2016
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4 Tips for a Smooth 510(k) Submission Process

4 Tips for a Smooth 510(k) Submission Process

By Jon Speer
Medical Device and Diagnostics Industry August 17th, 2016
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ISO 14971 or FMEA: Which Should You Use?

ISO 14971 or FMEA: Which Should You Use?

By Jesseca Lyons
Quality Digest August 9th, 2016
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First-In-Human Studies - What's The Rush?

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

By Jon Speer
Med Device Online July 27th, 2016
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Debunking 4 commonly held design control myths

Debunking 4 commonly held design control myths

By Jon Speer
MedCity News July 25th, 2016
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Navigating the difficult road of medical device product development while avoiding the common pitfalls

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

By Jon Speer
MedCity News July 14th, 2016
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Eight Reasons Why Your Design Controls and Risk Management Processes Fail

Eight Reasons Why Your Design Controls and Risk Management Processes Fail

By Jon Speer
Quality Digest July 5th, 2016
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Understanding ISO 14971 medical device risk management

Understanding ISO 14971 medical device risk management

By Jon Speer
MedCity News June 6th, 2016
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3 tips for applying risk management across medical device product development

3 tips for applying risk management across medical device product development

By Jon Speer
MedCity News May 26th, 2016
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The Definitive Guide to Responding to FDA 483 and Warning Letters

The Definitive Guide to Responding to FDA 483 and Warning Letters

By Jon Speer
Medical Design Technology May 19th, 2016
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What were the top reasons FDA issued device makers 483’s and warning letters in 2015

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

By Jon Speer
MedCity News May 19th, 2016
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8 Reasons Design Controls And Risk Management Processes Fail

8 Reasons Design Controls And Risk Management Processes Fail

By Jon Speer
Med Device Online May 19th, 2016
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How design controls apply to a 510(k)

How design controls apply to a 510(k)

By Jon Speer
MedCity News May 5th, 2016
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Get and stay on the FDA's good side with Jon Speer

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

Inspired Imua Podcast April 21st, 2016
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Why FMEA Is Not ISO 14971

Why FMEA Is Not ISO 14971

By Jon Speer
Quality Digest April 20th, 2016
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Are Design Control Myths Holding Back Your Product Development?

Are Design Control Myths Holding Back Your Product Development?

By Jon Speer
Med Device Online April 1st, 2016
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A Step-by-Step Guide to Complying with Medical Device QMS Requirements

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

By Jon Speer
Medical Design Technology March 9th, 2016
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MedTech Blunders in Risk Management

MedTech Blunders in Risk Management

By Jon Speer
MedTech Intelligence March 4th, 2016
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5 Tips to Help Your FDA 510(k) Submission (checklist included)

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

By Jon Speer
MedCity News March 1st, 2016
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Risk: Look at the Big Picture

Risk: Look at the Big Picture

By Jon Speer
MedTech Intelligence February 15th, 2016
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How to Prepare for an FDA Inspection

How to Prepare for an FDA Inspection

By Jon Speer
Quality Digest February 8th, 2016
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6 Development Steps To Fast-Track Your Medical Device's Path To Market

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

By Jon Speer
Med Device Online February 5th, 2016
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The Design Controls + Risk Management Connection: Using Design Reviews Effectively

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

By Jon Speer
Med Device Online January 10th, 2016
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An alarming device trend: Why getting 510(k) clearance alone is not enough

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

By Jon Speer
MedCity News December 16th, 2015
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7 Steps to Respond to FDA 483 Inspection Observations

7 Steps to Respond to FDA 483 Inspection Observations

By Jon Speer
MedTech Intelligence November 12th, 2015
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The Design Controls + Risk Management Connection — Verification, Validation & Risk Controls

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

By Jon Speer
Med Device Online November 16th, 2015
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The Importance of the Risk Management Plan

The Importance of the Risk Management Plan

By Jon Speer

Medical Design Technology November 10th, 2015

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

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

By Jon Speer
MedCity News November 9th, 2015
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Risk Management: A Total Product Life-cycle Process [Infographic]

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

By Jon Speer
Legacy MEDSearch November 6th, 2015
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Risk Management for Medical Devices: An Introduction to the Process [Infographic]

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

By Jon Speer
Qmed November 5th, 2015
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Risk management definitions you need to understand

Risk management definitions you need to understand

By Jon Speer
Mass Device November 5th, 2015
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The beginner's guide to MedTech design verification and validation

The beginner's guide to MedTech design verification and validation

By Jon Speer
MedCity News October 30th, 2015
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How to Avoid Exponentially Escalating Costs with Design Controls

How to Avoid Exponentially Escalating Costs with Design Controls

By Jon Speer
Qmed October 28th, 2015
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3 Tips for Incorporating Risk Management Throughout Medical Device Product Development

3 Tips for Incorporating Risk Management Throughout Medical Device Product Development

By Jon Speer
Medical Design Technology October 20th, 2015
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The Design Controls + Risk Management Connection — Intended Use & User Needs

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

By Jon Speer
Med Device Online October 19th, 2015
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5 tips to help you prepare for an FDA inspection

5 tips to help you prepare for an FDA inspection

By Jon Speer
MedCity News October 13th, 2015
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4 Reasons Your Risk Management Approach is Wrong

4 Reasons Your Risk Management Approach is Wrong

By Jon Speer
MedTech Intelligence September 28th, 2015
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How to make FDA work for you – ATL Device Night

How to make FDA work for you – ATL Device Night

By Nick Tippmann
Mass Device September 25th, 2015
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The $400,000 FDA compliance mistake you don’t want to make

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

By Jon Speer
MedCity News September 23rd, 2015
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5 Tips For Better Medical Device Risk Management

5 Tips For Better Medical Device Risk Management

By Jon Speer
Med Device Online September 15th, 2015
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How to define medical device design inputs and outputs

How to define medical device design inputs and outputs

By Jon Speer
MedCity News September 15th, 2015
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The Beginner's Guide to ISO 14971 Medical Device Risk Management

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

By Jon Speer
Medical Design Technology September 15th, 2015
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How medical device complaints can make you a better company

How medical device complaints can make you a better company

By Jon Speer
MedCity News September 10th, 2015
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Case Study: 5 Mistakes that lead to flushing $400,000 in fighting the FDA

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

By Jon Speer
OrthoStreams September 3rd, 2015
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How to improve your medical device startup’s funding chances

How to improve your medical device startup’s funding chances

By Jon Speer
MedCity News September 1st, 2015
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Stop Treating Risk Management & Design Controls As Checkbox Activities

Stop Treating Risk Management & Design Controls As Checkbox Activities

By Jon Speer
Med Device Online September 1st, 2015
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Three ways to determine whether your medical device company suffers from disconnect

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

By Jon Speer
MedCity News August 19th, 2015
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Is your risk management system for medical devices up to date?

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

By Jon Speer
MedCity News August 12th, 2015
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What's the best approach to medical device Design Reviews?

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

By Jon Speer
MedCity News August 5th, 2015
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Are We in the Golden Age of Medical Devices?

Are We in the Golden Age of Medical Devices?

By Jon Speer
Medical Design Technology July 29th, 2015
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5 Tips To Help Your FDA 510(k) Submission (Checklist Included)

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

By Jon Speer
Med Device Online July 16th, 2015
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Top Three Document Management Tips for Medical Device Companies

Top Three Document Management Tips for Medical Device Companies

By Jon Speer
Quality Digest Jon Speer & Alex Morris on July 8th, 2015
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3 steps to getting your medical device startup off the ground

3 steps to getting your medical device startup off the ground

By Jon Speer
MedCity News July 1st, 2015
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Regulatory classification 101: A guide to how your medical device will be classified

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

By Jon Speer
MedCity News June 22nd, 2015
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What issues draw the most attention in FDA medical device inspections?

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

By Jon Speer
MedCity News June 8th, 2015
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The Medtech Adventures of Eddy the Engineer

The Medtech Adventures of Eddy the Engineer

By Jon Speer
Qmed June 2nd, 2015
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15 items medical device startups need to address

15 items medical device startups need to address

By Jon Speer
MedCity News May 27th, 2015
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Why medical device startups need to master juggling and balancing with focus

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

By Jon Speer
MedCity News May 13th, 2015
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4 medical device quality system musts for startups

4 medical device quality system musts for startups

By Jon Speer
MedCity News April 30th, 2015
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The Art Of Medical Device Design Inputs

The Art Of Medical Device Design Inputs

Med Device Online April 27th, 2015
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Eight Questions That Define Your Medical Device User Needs

Eight Questions That Define Your Medical Device User Needs

By Jon Speer
Quality Digest April 21st, 2015
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2 things you should do asap when starting a medical device project

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

By Jon Speer
MedCity News April 16th, 2015
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Your 5 Step Blueprint for Great MedTech Design Reviews

Your 5 Step Blueprint for Great MedTech Design Reviews

By Jon Speer
Qmed April 9th, 2015
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How to run effective medical device design reviews

How to run effective medical device design reviews

By Jon Speer
MedCity News April 9th, 2015
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3 Tips for Managing Your Medical Device Design History File

3 Tips for Managing Your Medical Device Design History File

By Jon Speer
Medical Design Technology March 31st, 2015
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From Idea to Market Release: Your Quick Guide to FDA Design Controls

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

By Jon Speer
MedCity News March 30th, 2015
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How Medtech Startups Can Navigate Design Controls

How Medtech Startups Can Navigate Design Controls

By Jon Speer
Qmed March 12th, 2015
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