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Jon Speer

Jon Speer
Jon is the founder and VP of QA/RA at Greenlight Guru (quality management software exclusively for medical device companies) & a medical device guru with nearly 20 years industry experience. Jon knows the best medical device companies in the world use quality as an accelerator. That's why he created Greenlight Guru to help companies move beyond compliance to True Quality.

Author's Posts

How to Integrate Complaint Handling and Risk Management - Featured Image

How to Integrate Complaint Handling and Risk Management

Did you know that complaint handling continues to be a big reason medical device companies receive 4...
How to Streamline the Customer Complaint Handling Process - Featured Image

How to Streamline the Customer Complaint Handling Process

It can be quite nerve-wracking the very first time your medical device company receives a complaint ...
What is Software as a Medical Device (SaMD)? - Featured Image

What is Software as a Medical Device (SaMD)?

Medical devices are a big business covering a wide range of modalities and applications. To ensure t...
Here Are the 4 Types of FDA Inspections You Need to Understand - Featured Image

Here Are the 4 Types of FDA Inspections You Need to Understand

Every medical device manufacturer knows that, at some point, they should expect the FDA to arrive to...
Ultimate Guide to Corrective and Preventive Action (CAPA) for Medical Devices - Featured Image

Ultimate Guide to Corrective and Preventive Action (CAPA) for Medical Devices

What Is This CAPA Guide About? As an experienced medical device professional who has worked with doz...
How to Prepare for the Medical Device Single Audit Program - Featured Image

How to Prepare for the Medical Device Single Audit Program

  How is your understanding of the Medical Device Single Audit Program (MDSAP)?
How MEDDEV 2.7.1 Rev 4 Affects Medical Device Manufacturers - Featured Image

How MEDDEV 2.7.1 Rev 4 Affects Medical Device Manufacturers

Up until the latest revision of MEDDEV 2.7.1 was published on June 29th, 2016, clinical data provide...
Why the 510(k) Process Is So Stressful & How You Can Help Streamline It - Featured Image

Why the 510(k) Process Is So Stressful & How You Can Help Streamline It

  My guest today is Juan Carlos Serna, the co-founder of Right Submission. If you have been in the m...
Standard Conformity or Regulatory Compliance? Distinguishing the Two - Featured Image

Standard Conformity or Regulatory Compliance? Distinguishing the Two

So, you have a certificate hanging on your wall showing that you’ve passed an audit and conform with...
What Does a Risk-Based QMS Mean? - Featured Image

What Does a Risk-Based QMS Mean?

What exactly is a risk-based QMS? This is a timely topic to get into. In 2016, ISO 13485 was updated...
What do You Need to Know about the 510(k) Submission Process - Featured Image

What do You Need to Know about the 510(k) Submission Process

Have you ever been through the experience of having the FDA refuse to accept your 510(k)? This has h...
FDA Inspections and ISO Audits: What is the Difference? - Featured Image

FDA Inspections and ISO Audits: What is the Difference?

It’s every medical device manufacturer's favorite time… … the arrival of an FDA inspector or ISO aud...

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