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Case Studies
Supporting Dual Regulatory Pathways for Continuous Hormone Monitoring IVDs
Challenges
The manufacturer developed an innovative in vitro diagnostic (IVD) platform for continuous hormone monitoring, including:
- A cortisol solution positioned as a wellness product in Canada and the United States
- A progesterone solution regulated as a medical device
Operating across different regulatory paradigms within a single technology platform created complexity around:
- Maintaining a unified, compliant quality management system (QMS)
- Clearly separating wellness and medical device claims
- Preparing for US market entry while meeting medical device regulatory expectations
- Scaling and improving manufacturing processes to support growth and compliance
Solutions
We implemented a cohesive regulatory and quality strategy that addressed both wellness and medical device requirements, including:
- Establishment and alignment of a QMS compliant with US medical device regulations
- Regulatory support for US market entry
- Clear differentiation between wellness and medical device pathways within the same platform
- Ongoing support to strengthen and optimize manufacturing processes in line with quality and regulatory requirements
Successful readiness for US market entry supported by a compliant, scalable QMS
Reduced regulatory risk through clear separation of wellness and medical device positioning
Improved manufacturing robustness and process control
A quality and regulatory foundation capable of supporting future product expansion
Results
CONCLUSION
This case study illustrates how innovative diagnostic platforms can successfully navigate both wellness and medical device frameworks when supported by a structured regulatory and quality strategy. By aligning compliance, claims, and manufacturing early, the manufacturer was positioned for sustainable growth as the technology and regulatory landscape evolve.
TESTIMONIAL
"Working with Hasnaa has been a real asset to our QA/RA efforts. Her openness to new ideas, combined with her rigorous, regulation-driven approach, helped us focus on what truly matters and streamline the core of our quality systems. Her guidance brought clarity and confidence to our regulatory strategy as we continue scaling Eli."