Compliance News You Can Use – November 2014

Getting a Safety Mark is Never as Straightforward as it Seems

Most of our discussions with clients begin like this: “I need to get a UL mark on my product, but it should be pretty easy because all of the major components have a UL mark…”, or “I’ve got almost the exact same product as this one with an ETL mark, so I don’t need to do any testing…”

The reality is that most people think that getting a DFSA-Flow-20141product certified by UL, ETL, CSA, or another NRTL is a relatively easy task. After all, product development engineers know how to design safe products – so confirming it with testing should be a smooth process. This is a great theory, but the opportunities for test failures and non-compliances are literally endless, without knowing exactly what engineers who work for major NRTLs are looking for.

Ideally, a product should be submitted as early as possible during its development. Because we know the value added when you build solutions into products up front, we created Design For Safety Approvals – DFSA™. Bring us in at the front-end. Save your company lost time, money and customers by understanding the compliance requirements in detail before products come off the drawing board.

FDA 510(k) Submissions

The FDA registration application process is full of potential obstacles a company must overcome in order to bring its medical device to market in the United States. Product Safety Consulting’s experts will guide you through the entire procedure, so you can get your product to market safely and cost efficiently.

The 510(k) submission includes a description of the device, clinical and preclinical/non-clinical performance data, device labeling and instructions for use, comparative products and/or standard methods documentation. The FDA approval process cannot be rushed through, with the average submission decision taking between 90-100 business days.

Our consulting team has extensive experience in:

  • Quality Systems Development/Remediation Training
  • Product Verification & Validation Regulatory Compliance
  • Risk Management Production and Process Controls
  • Risk-Based Planning & Analysis Quality Assurance & Validation
  • Design Controls Business Process Re-engineering
  • New Product Development Documentation & Change Controls
  • SDLC CAPA
  • Management Controls Project/Program Management
  • Complaints, Recalls & MDR’s

Contact Alan Gradei of PSC with any questions.

Recent Successes

A client came to us with an issue on their Linear Luminaire NRTL project.  The flame rating of the diffuser was 94V-2. The NRTL engineer indicated the flame rating of a diffuser needed to be 94-5V.  After reviewing the construction and the requirements, we were able to provide a solution that got his circuit to Low Voltage Limited Energy, which allowed the use of their existing material. These types of successes are a common occurrence at Product Safety Consulting!

Calendar of Events

The LED Show
Feb. 24-26, 2015
Las Vegas, NV

ISPCE 2015
IEEE Symposium on Product Compliance Engineering
May 18-20, 2015
Chicago, IL