The Line

A place for Striper blog posts, articles, and technical information. Check in often to see what's on the line.

Nov 21, 20241 min read

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:...

Oct 24, 20241 min read

Presented at the IEEE Symposium on Product Compliance Engineering, Bloomington, MN

Sep 3, 20243 min read

The final step in the CE marking process involves affixing the CE mark to the product. However, there a few considerations first...

Aug 6, 20243 min read

The EU Declaration of Conformity is a critical part of the CE marking process, declaring compliance with relevant directives and standards.

Jul 30, 20244 min read

The technical file is your passport to the European market, providing a comprehensive record of compliance with EU regulations.

Jul 22, 20248 min read

Developing products for the European market requires a proactive approach to safety and reliability. In line with the quality management pri

Jul 16, 20244 min read

An ISO 9001 product development process, presented in flowchart form.

Jul 15, 20245 min read

In this article we give a practical example of choosing directives and applying standards for a simple product.

Jul 7, 20247 min read

A guide to understanding product CE marking, a necessary step to access the European Union.

Jun 19, 20243 min read

Striper Solutions LLC prioritizes regulatory compliance consulting