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Bring new technology from ideation to the marketplace Bring new technology from ideation to the marketplace Bring new technology from ideation to the marketplace Bring new technology from ideation to the marketplace
  • Capabilities
    • Commercialization
    • Mechanical & Electrical Design/Engineering
    • Software & Web Development
    • Design & Human Factors
    • Quality Management
    • Clinical Verification, Regulatory, & Reimbursement Strategy
    • Technology: Planning, Protecting, & Documenting
  • Expertise
    • Why Simbex?
    • Portfolio
    • Wearables
    • Commercialization Centers
    • Technology Transfer Offices
    • News & Blog
  • About
    • Leadership
    • Our Team
    • Our Story
    • Culture
    • Careers
  • Get Started

Blog

 FDA Detailed Expanded Use of Remote Regulatory Assessments in New Guidance and CMS Proposed Updates to Remote Therapeutic Monitoring in 2023 Fee Schedule

FDA Detailed Expanded Use of Remote Regulatory Assessments in New Guidance and CMS Proposed Updates to Remote Therapeutic Monitoring in 2023 Fee Schedule

August 7, 2023

FDA is releasing a draft guidance on the expanded use of remote regulatory assessments (RRAs) and how the FDA generally intends this tool, once finalized, to be incorporated consistently across [...]

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 Q1 Medical Device Recalls Linked to Unprecedented Level of Faulty Manufacturing and CMS announces Transitional Coverage for Emerging Technologies

Q1 Medical Device Recalls Linked to Unprecedented Level of Faulty Manufacturing and CMS announces Transitional Coverage for Emerging Technologies

July 11, 2023

According to the most recent "U.S. Product Safety And Recall Index" report by Sedgwick, manufacturing defects are the leading cause for product recalls in 2023 through the month of March.

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 Embracing Elegance in Medical Device Design: A Path to Exceptional Solutions

Embracing Elegance in Medical Device Design: A Path to Exceptional Solutions

June 26, 2023

In medical device engineering, the pursuit of elegance in design goes far beyond surface aesthetics, embodying a philosophy that seamlessly blends form, function, and usability to create [...]

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 AAMI and BSI Partner to Publish Guidance on Artificial Intelligence and Reimbursement lags for Prescription Digital Therapeutics

AAMI and BSI Partner to Publish Guidance on Artificial Intelligence and Reimbursement lags for Prescription Digital Therapeutics

June 2, 2023

Read about AAMI and BSI partner is to publish guidance on artificial intelligence and reimbursement lags for prescription digital therapeutics.

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 Fall Detection: Design Challenges, Physics Modeling, and Targeted Testing

Fall Detection: Design Challenges, Physics Modeling, and Targeted Testing

May 26, 2023

Wearable motion sensors are everywhere, including in smart watches and fitness trackers. Because of this, it is now possible to design wrist-worn products that detect when a person falls and [...]

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 FDA Issues Predetermined Change Control Plan for AI/ML-Enabled Device Draft Guidance and EPA proposes rules on EtO medical device sterilization

FDA Issues Predetermined Change Control Plan for AI/ML-Enabled Device Draft Guidance and EPA proposes rules on EtO medical device sterilization

May 9, 2023

Read about the FDA-issued Marketing Submission Recommendations and the new rules the EPA has proposed for medical device sterilization.

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 Integrating Data Quality Improvement into your Data Import Processes

Integrating Data Quality Improvement into your Data Import Processes

May 8, 2023

In the world of data management, maintaining clean and accurate databases is key to the success of any organization.

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 Principal Component Analysis

Principal Component Analysis

April 27, 2023

There are some tools that punch above their weight, and with some beautiful math, can produce powerful insights into incredibly complex and large datasets. One of these elegant tools that we use [...]

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 Examples of Diagnostic Tools in Action

Examples of Diagnostic Tools in Action

April 19, 2023

In our last article, we discussed how Simbex’s approach to diagnosing and resolving performance issues throughout the medical device development process, using design techniques such as building [...]

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 Diagnosing Problems During Medical Device Development

Diagnosing Problems During Medical Device Development

April 19, 2023

The word diagnosis is made of up of two Greek roots meaning “to know throughout” or to “understand completely”.  We usually think of diagnosis in the context of illness, but it applies to problem [...]

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Simbex

Simbex is an experienced medical device and consumer health product design and development partner that excels in transforming your most complex ideas into game-changing commercial solutions.

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