About Client

In the fast-paced landscape of medical device development, a visionary point-of-care COVID testing device company sought regulatory approval from Health Canada and the FDA. Recognizing the complexity of international markets, they partnered with Elexes, a specialized consulting firm to streamline their quality management system.

Device Overview

The company faced dual challenges of meeting Health Canada’s stringent requirements and aligning with the FDA’s quality system regulations. Their existing system lacked the harmonization required for both regions, and a comprehensive overhaul was essential.

Key Takeaways

Building on the Pre-Submission insights and addressing challenges, Elexes’ regulatory affairs team provide comprehensive support for the 510(k) submission.

Proactive Procedures

Tailoring procedures to regulatory nuances is crucial. The complaint handling procedure, when implemented proactively, acts as a preemptive regulatory shield.

MDSAP as a Catalyst

MDSAP certification not only ensures compliance with multiple jurisdictions but can expedite overall regulatory approval processes.

Expert Guidance Matters

Engaging Elexes who is well versed in MDSAP intricacies ensured a smoother journey; real-world examples and targeted interventions save both time and resources.

Success Statement

In this success story, the confluence of regulatory expertise and proactive quality management resulted in swift MDSAP certification, opening doors to both Health Canada and the FDA. The case exemplifies the paramount importance of strategic partnerships in the dynamic landscape of global medical device compliance.


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