International Market Access.
Regulatory documentation and market-maintenance planning outside the United States.
Plan for the markets that matter to your product.
Requirements differ across markets. Crossroads helps organize the regulatory work around your target geographies, existing documentation, and plans for the product.
European Union documentation
Review documentation needs for the EU Medical Device Regulation, including technical documentation and the assessment of product changes.
Canadian licensing
Support the documentation associated with medical-device license applications and amendments.
International registrations
Identify registration and documentation considerations for your target markets. Local representation and specialist requirements are established separately.
Keeping markets open
Assess the impact of changes in products, regulations, and standards on existing regulatory documentation and market authorizations.
A new geography. An existing market. A changed requirement.
International work can focus on one market or coordinate documentation across several. The approach reflects the requirements of each target market.
How we work togetherWhat to bring
to the first discussion.
- Target countries and launch priorities
- Existing authorizations and technical documentation
- Planned product or manufacturing changes
A brief, non-confidential overview is enough to begin. Detailed documents can be discussed once the engagement arrangements are agreed.
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