Combination products are therapeutic and diagnostic products that combine drugs, devices, and / or biological products. Because combination products involve components that would normally be regulated under different types of regulatory authorities they raise challenging regulatory, policy, and review management challenges. 
Differences in regulatory requirements for component testing impacts the processes for all aspects of product development and management, including preclinical testing, clinical investigation, marketing needs, manufacturing and quality control and any post-approval modifications.
Contact IDC for design insights on how our medical device testing technologies such as the M1075 contribute to the challenges in manufacturing and quality control in these key medical product areas.
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