Medical Device Quality, Regulatory and Product Development Blog

What is Software as a Medical Device (SaMD)?

By Jon Speer on November 13, 2017

Medical devices are a big business covering a wide range of modalities and applications. To ensure t...

Understanding How to Use Real-World Evidence for Medical Device Regulatory Decisions

By Nick Tippmann on November 8, 2017

The topic of Real-World Evidence is generating a lot of discussion lately, especially after the draf...

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

By Jon Speer on November 6, 2017

Every medical device manufacturer knows that, at some point, they should expect the FDA to arrive to...

Greenlight Guru Extends Platform with New Product, Grow, to Streamline PostMarket Quality Processes

By Nick Tippmann on October 30, 2017

The only eQMS specifically for medical device will enable companies to move beyond baseline complian...

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

By Jon Speer on October 27, 2017

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

By Jon Speer on October 23, 2017

How is your understanding of the Medical Device Single Audit Program (MDSAP)?

Lessons to Be Learned from Recent FDA Inspections

By Nick Tippmann on October 18, 2017

Something that you might find surprising is the number of medical device companies that are simply n...

How MEDDEV 2.7.1 Rev 4 Affects Medical Device Manufacturers

By Jon Speer on October 16, 2017

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

By Jon Speer on October 11, 2017

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

By Jon Speer on October 9, 2017

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?

By Jon Speer on October 1, 2017

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

By Jon Speer on September 24, 2017

Have you ever been through the experience of having the FDA refuse to accept your 510(k)? This has h...

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