Industry Executives to Present Innovative and Compliant Solutions for Clinical Data Managers (Chicago, IL) – For the second consecutive year, Q1 Productions will host the Innovations in Clinical Data Management Conference, bringing the most valuable...
Jodie Bastian Director of Quality Systems STRYKER Why is the quality management system within the medical device industry important? Its true intent is simple: to define and deliver on customer requirements, safely, effectively and consistently. Understanding...
Regulatory Approvals in China, 510(k) Guidance Among This Years’ Discussion Topics (Chicago, IL) – For the fourth straight year, Q1 Productions will host the annual Medical Device Regulatory Clearance and Approval Conference, offering regulatory affairs...
Barry Silva Senior Quality Systems Engineer BIO-DETEK/ZOLL MEDICAL Why is the quality management system within the medical device industry important? The QMS creates a level playing field and shows current and potential customers that their products will reside...
The Food and Drug Administration has announced plans to begin regulating Laboratory Developed Tests (LDTs) to ensure that tests used to diagnose thousands of diseases and other conditions are reliable and accurate. In light of this important announcement, Q1...