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Finding & Selecting the Best Medical Device eQMS

9/12/2024

 
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 I’ve had the good fortune to help dozens of clients select eQMS tools and scale them to operational status.  Here’s what I’ve seen from a decision-making perspective, and of course some learned lessons along the way.

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FDA Announcement: 21 CFR 820 and ISO 13485 Guidance

2/22/2024

 
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Big changes to U.S. medical device quality regulations

​On February 2, 2024, the FDA officially announced its plans to amend 21 CFR Part 820 to align more closely with ISO 13485—the globally recognized standard for medical device quality systems. While many OEMs already follow ISO 13485, those who don’t will now have until February 2, 2026, to make the transition. Here's what you need to know about the shift, what’s changing, and how to prepare.

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Over-Complicating Your Work Creates More Problems Than It Solves

9/20/2022

 
​“They gave us world class, but all we needed was the basics.”

​Last week I was speaking with a VP of Quality at a small medical device company at which point he politely complained to me about a recent experience he had with a consultant their company brought onboard.  The company was implementing a new online quality management system (QMS) and was utilizing this consultant to get it up and running.

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Addressing QMS Remediation in Class III Medical Devices

7/26/2022

 
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Our client, a Class III medical device company, was issued an FDA 483 warning letter due to product field failures and QMS issues posing life threatening risks to implant patients.

The Square-1 Engineering subject matter experts (SME team) were brought in to identify & correct systems and process issues across six (6) functional departments and two (2) manufacturing  locations domestically.  As you can guess our clients’ situation was dire due to several implant failures in the field.

We invite you to download the case study below to learn how we saved our client $4.5M while successfully concluding the remediation project.

square-1_engineering_qms_remediation_project_case_study_class_iii.pdf
File Size: 231 kb
File Type: pdf
Download File
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Medical Device Remediation, Top Two Keys To Success

3/8/2021

 
​Want to get through your remediation project successfully?  Doing these two things helps dramatically increase your chances of success.
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    About the Author

    Travis Smith is the founder and managing director of Square-1 Engineering, a medical device consulting firm, providing end to end engineering and compliance services.  He successfully served the life sciences marketplace in SoCal for over 15 years and has been recognized as a ‘40 Under 40’ honoree by the Greater Irvine Chamber of Commerce as a top leader in Orange County, CA.

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