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.
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.
