How Our Turnkey Regulatory Solution Accelerated Global Market Readiness for a Medical Aesthetics Leader
End-to-end QARA partnership for faster submissions, supplier audits, and post-market excellence.Strengthening Regulatory Resilience and Operational Excellence for Rapid Global Expansion
A top-tier U.S.-based medical aesthetics OEM engaged Syrma Johari MedTech to streamline its global regulatory and quality operations amid rapid international expansion. The client faced growing complexity in managing multi-country submissions, supplier qualification, and post-market compliance within a diverse, highly regulated ecosystem.
Syrma Johari MedTech delivered a turnkey solution encompassing supplier audits, Design History File (DHF)/Device Master Record (DMR) remediation, risk management, and product complaints handling. The engagement centralized technical documentation, optimized the supplier evaluation process, and improved complaint resolution times. The established scalable framework was compliant with ISO 13485, ISO 14971, FDA 21 CFR Part 820, and EU MDR requirements.
This integrated approach helped the client to significantly accelerate market readiness and reduce operational burdens.
Key Outcomes
- 125% improvement in supplier oversight and compliance
- 40% reduced operational costs
- 55% increase in bandwidth of the client’s internal resources
Simplify Compliance. Accelerate Market Success.
Syrma Johari MedTech offers end-to-end regulatory affairs services that help manufacturers ensure compliance across every stage of the product lifecycle. Our experts work closely with your teams to create documentation and manage submissions, ensuring faster market access and regulatory sustenance.
We support large, medium, and small medical device and in vitro diagnostic (IVD) companies in minimizing compliance risks and gaining a competitive edge in diverse markets.