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The Line
A place for Striper blog posts, articles, and technical information. Check in often to see what's on the line.
Update to the AI Challenge: Using LLMs for Regulatory Compliance
Like any tool, AI requires an understanding of its operation and limitations. This article provides valuable insights into the importance of understanding both the capabilities and limitations of AI when used for regulatory compliance.
May 305 min read
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Achieving Maximum Benefit From Consultants: CNET Presentation for the Medical Development Group (MDG Boston)
Thank you to everyone at MDG Boston for allowing CNET to speak on Achieving Maximum Benefit from Consultants
May 291 min read
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CNET Consultants Series Part 3: FDA Medical Device Regulatory Process
Join the IEEE Boston Consultants Network on Tuesday, December 3rd, at 7 pm for the third installment of our Consultants Series:...
Nov 21, 20241 min read
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Mastering EMC: The Importance of Pre-Compliance Testing
Presented at the IEEE Symposium on Product Compliance Engineering, Bloomington, MN
Oct 24, 20241 min read
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Unlocking the European Market: Affixing the CE Mark
The final step in the CE marking process involves affixing the CE mark to the product. However, there a few considerations first...
Sep 3, 20243 min read
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Unlocking the European Market: The EU Declaration of Conformity
The EU Declaration of Conformity is a critical part of the CE marking process, declaring compliance with relevant directives and standards.
Aug 6, 20243 min read
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Unlocking the European Market: The CE Technical File
The technical file is your passport to the European market, providing a
comprehensive record of compliance with EU regulations.
Jul 30, 20244 min read
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Unlocking the European Market: The CE Risk Assessment
Developing products for the European market requires a proactive approach to safety and reliability. In line with the quality management pri
Jul 22, 20248 min read
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ISO 9001:2015 Product Development Flowchart
An ISO 9001 product development process, presented in flowchart form.
Jul 16, 20244 min read
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Unlocking the European Market: Navigating EU Directives and Standards
In this article we give a practical example of choosing directives and applying standards for a simple product.
Jul 15, 20246 min read
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Unlocking the European Market: A Step-by-Step Guide to CE Marking
A guide to understanding product CE marking, a necessary step to access the European Union.
Jul 7, 20247 min read
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New Direction, Same Dedication: Striper Solutions Prioritizes Regulatory Compliance
Striper Solutions LLC prioritizes regulatory compliance consulting
Jun 19, 20243 min read
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