Regulatory Affairs Outsourcing: Powering MedTech’s Next Wave of Growth

Regulatory Affairs has emerged as one of the most critical and resource-intensive functions driving MedTech growth.

MedTech companies are moving away from building large, in-house RA teams. Instead, they are adopting hybrid models, combining internal expertise with specialized external partners for dynamic market demands. This marks a decisive shift toward flexible, outsourced RA strategies.

A Comprehensive Roadmap for Medtech Leaders Seeking to Streamline Regulatory Operations

This article explores how fast-growing medical device and diagnostics companies are rethinking their RA structures for driving growth. It explains how organizations are shifting focus from the in-house vs. outsourced debate, adopting blended resourcing models with a balance of expertise and cost efficiency.

In this report, Syrma Johari MedTech examines the core factors that influence an optimal RA setup: device classification, company maturity, market footprint, and cross-functional dependencies between the RA, quality, and clinical teams.

Through detailed frameworks and case-based analysis, the article reveals how leading MedTech OEMs combine internal and outsourced execution to accelerate submissions and strengthen compliance. Gain insights into the evolution of regulatory operations through trends such as RegOps digitization, PMS- and MoCRA-driven specialist outsourcing, and offshore RA support.

Curious how your current RA setup compares?

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