Regulatory and quality experience, put to work for medical-device companies.
Crossroads Regulatory Consulting connects regulatory and quality expertise with the work of bringing medical devices to market and keeping them there.
From a startup’s first quality system to a product change affecting several markets, the work starts with the device, its intended use, and the decision ahead.
You work directly with Nancy Gertlar, the principal consultant. She brings the experience and continuity of a senior regulatory and quality leader to each engagement.
Working with Crossroads
Principal consultant
FRAPS
RAC-USA, RAC-CAN, RAC-EU
MS, MBA, IMBA
Experience leading regulatory and quality work, with direct involvement in yours.
Nancy has worked with medical-device businesses from early development through international market access and ongoing product support. Her background combines regulatory submissions, quality-system implementation, and the evaluation of product changes.
She works with your team to understand the issue, establish priorities, and carry the agreed work forward. Advice and documentation are developed with the people who will use them, so the knowledge stays with your organization.
Her experience across device technologies and participation in ISO standards working groups bring both product context and a practical understanding of requirements to the discussion.
Explore our device expertiseRegulatory and quality work grounded in the challenges medical-device teams face.
Experience with U.S. submissions, EU MDR certification, and international registrations informs how we plan regulatory work. We help connect the intended use, supporting evidence, and documentation with the requirements of each target market.
Our background includes designing and implementing quality systems for startups and established medical-device businesses. That experience helps us develop processes that reflect the product, the organization, and the people responsible for the work.
Software updates, hardware changes, and new market requirements can affect an existing product. Experience across device categories and international markets helps us assess those changes and keep regulatory and quality work connected throughout the lifecycle.
Professional leadership and knowledge shared.
Nancy’s involvement with the Regulatory Affairs Professionals Society (RAPS) reflects her commitment to the regulatory profession through leadership, training, and the development of other professionals.
About RAPSNancy has served on the RAPS Board of Directors, as Florida Chapter Chair, and as chair of the Fellow Selection Committee.
A RAPS Fellow, Nancy holds Regulatory Affairs Certification credentials for the United States, Canada, and European Union: RAC-USA, RAC-CAN, and RAC-EU.
Nancy has contributed as a speaker and trainer at RAPS annual conferences, Horizons, and chapter events, sharing practical regulatory experience with other professionals.
Tell us about your product, your priorities, and the question ahead. A brief, non-confidential overview is enough to begin.
Contact Crossroads