About Crossroads.
A medical-device regulatory and quality consulting practice built around thoughtful, practical work.
The company
Where regulation,
compliance, and
quality meet.
Crossroads Regulatory Consulting helps organizations consider regulatory and quality responsibilities together.
The practice focuses on the questions behind a submission, a quality process, a product change, or a business decision. The work starts with understanding the device and defining the support required.
A clear scope and a direct working relationship sit at the center of that approach.
Working with CrossroadsThe expertise behind the practice
Nancy Gertlar
Principal consultant
FRAPS, RAC
MS, MBA, IMBA
Nancy’s professional background spans regulatory affairs and quality management in medical-device companies, from startups to international organizations.
Her career includes regulatory and quality roles at Philips, ConMed, McKesson, and other device manufacturers, alongside consulting and mentoring work.
This experience informs the Crossroads practice. Previous roles and responsibilities describe her professional background; the scope of each current engagement is agreed separately.
Our approach
Clear responsibilities.
Practical collaboration.
Product context first
Consider the device, its intended use, and the stage of the work before defining the regulatory or quality task.
Scope made explicit
Establish what the engagement includes, what information it relies on, and which responsibilities remain with the organization.
Knowledge shared
Make the work understandable to the people who will carry it forward.
Start a conversation
Discuss your regulatory or quality needs.
Tell us about your product, your priorities, and the question ahead. A brief, non-confidential overview is enough to begin.
Contact Crossroads