FDA Regulatory Support
U.S. medical-device pathways, submission planning, and FDA interactions.
Explore FDA regulatory supportRegulatory consulting
for medical device
companies.
Guidance on FDA regulatory support, international market access, and quality systems. Clear support for your product and the decisions ahead.
Explore our services
Where regulation,
compliance, and
quality meet.
Medical-device decisions rarely sit within a single discipline.
A market-entry plan depends on product evidence. A design change can affect an existing authorization. A quality process needs to work for the people responsible for it.
Crossroads brings these considerations into the same conversation, helping organizations define the regulatory and quality work their situation calls for.
About usFind the support your next decision needs.
Regulatory and quality support, shaped around your product, your markets, and the decisions ahead.
International Market Access
Regulatory documentation and market-maintenance planning outside the United States.
Explore international market accessQuality Systems & Compliance
Quality-system assessment, process development, and preparation for audits.
Explore quality systems & complianceProduct Lifecycle
Regulatory and quality considerations through development, change, and post-market activities.
Explore product lifecycleAdvisory & Leadership
Senior regulatory and quality perspective, fractional support, and team development.
Explore advisory & leadershipDifferent products.
Different considerations.
Experience across medical-device categories.
Explore our expertise
A clear plan.
A direct working relationship.
Start with the product and the question. Together, we establish the work involved, the responsibilities, and the appropriate form of support.
How an engagement worksSenior judgment.
Direct involvement.
Crossroads brings senior regulatory and quality expertise directly into your business, with the principal involved in every engagement.
Nancy Gertlar
Principal consultant
FRAPS, RAC · MS, MBA, IMBA
Nancy’s background spans regulatory affairs and quality management in medical-device companies, from startups to international organizations.
That experience informs the advice, attention, and working relationship Crossroads brings to each engagement.
Meet the principalDiscuss 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