Medical Device Quality, Regulatory and Product Development Blog

FDA QSIT: Preparing Your Medical Device Company for an Inspection

By Jon Speer on June 17, 2019

Preparing for an FDA QSIT inspection can be a daunting task for medical device manufacturers. Many c...

Is Your Medical Device Company CAPA Happy?

By Nick Tippmann on June 12, 2019

The medical device industry could be more proactive than reactive when managing systemic issues. We’...

10 Essentials for Writing a Clear Product Requirements Document [Guide+Checklist]

By QRA Corp on June 9, 2019

We distilled the insights from our research into this one guide + checklist that we hope will help a...

Integrating Human Factors into Design Controls to Improve Patient Outcomes

By Nick Tippmann on June 5, 2019

The relationship between human factors and design controls often creates confusion in the medical de...

5 Most Common Mistakes Made When Implementing ISO 14971

By Jon Speer on June 2, 2019

ISO 14971 is a descriptive regulatory standard that provides guidance for how to apply risk manageme...

Greenlight Guru In the Classroom: A University's Real-world Approach

By Nick Tippmann on May 29, 2019

Greenlight Guru continues to bridge the gap in biomedical engineering education by helping students ...

The Essential Guide to Preparing your QMS for EU MDR

By Jon Speer on May 27, 2019

How prepared is your quality management system for the new requirements of EU MDR for medical device...

Improving the Colon Cancer Screening Experience

By Nick Tippmann on May 24, 2019

Preparation for a colonoscopy is not a pleasant or positive experience. From laxatives to the invasi...

EU MDR: Not All Doom and Gloom

By Nick Tippmann on May 22, 2019

Feeling gloom, doom, concern, and fear about the new European Union Medical Device Regulation (EU MD...

Qualifying Your Suppliers Using a Risk-based Approach

By Jon Speer on May 19, 2019

This notion of risk-based processes within quality systems is something that has become part of our ...

Biocompatibility Nuances and its Impact on Medical Devices

By Nick Tippmann on May 15, 2019

Biocompatibility can be challenging and frustrating when developing a medical device. Why do you hav...

How to Write Effective SOPs for Medical Devices

By Jon Speer on May 12, 2019

Writing and enforcing standard operating procedures (SOPs) for medical devices is required by FDA, I...

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