Article | June 7, 2022

How Early Raw Material Testing Mitigates Product Development & Regulatory Risk

Source: Secant Group

By Kitu Patel and Brendan Nicholson, Secant Group; and Stacey McElhaney, SanaVita Medical

Life Science Connect Article 1

Early analytical testing offers medical device manufacturers the opportunity to produce more robust data to proactively mitigate risks to be better prepared for the regulatory submission process. This approach enables time and cost savings while contributing to a higher-quality final product. Consider, too, that industry and regulatory agencies are trending toward requiring more analytical data earlier in the development cycle.

Additionally, recharacterizing medical device components and subassemblies after each process stage helps device manufacturers understand elements of a specific material that might alter it in some way (e.g., leachables caused by contact with raw materials), allowing for remediation well in advance of the submission process.
A supplier with manufacturing and testing under the same roof can track material trends to proactively address potential issues, as well as tailor its report to a customer's needs, because the supplier knows its materials better than anybody else, including how the material integrates into the manufacturer’s product.


Get unlimited access to:

Trend and Thought Leadership Articles
Case Studies & White Papers
Extensive Product Database
Members-Only Premium Content
Welcome Back! Please Log In to Continue. X

Enter your credentials below to log in. Not yet a member of Med Device Online? Subscribe today.

Subscribe to Med Device Online X

Please enter your email address and create a password to access the full content, Or log in to your account to continue.


Subscribe to Med Device Online