We help Your Medical Device Companie to enter the European Market
Get updates on regulatory trends and medical innovation.
We bring deep expertise and proven results to every regulatory challenge.
Navigate complex FDA, EMA, and global regulatory frameworks with confidence.
Learn more →Speed up time-to-market with streamlined regulatory strategies and documentation.
Learn more →Ensure your medical devices meet international standards and regulatory requirements.
Learn more →From concept to clearance, we guide medical device innovators through every stage of the regulatory journey. Our team brings decades of combined experience across multiple jurisdictions.
Whether you're pursuing 510(k) clearance, CE marking, or global market access, we deliver strategic guidance and hands-on support.
We support FDA 510(k), PMA, De Novo, CE marking under MDR/IVDR, Health Canada, and other international pathways.
Timelines vary by pathway and product complexity. 510(k) typically takes 3-6 months, while PMA can take 1-2 years. We help accelerate the process.
Yes. We provide clinical strategy, protocol development, site selection, and regulatory submissions for IDE and other clinical pathways.
We work with medical device manufacturers, digital health companies, diagnostic labs, and pharmaceutical firms across all therapeutic areas.
We offer project-based pricing, monthly retainers, and hourly consulting. Pricing depends on scope, complexity, and timeline.
Absolutely. We assist with post-market surveillance, adverse event reporting, quality system audits, and ongoing regulatory maintenance.
AX1 Medical brings a proven track record of successful regulatory submissions and market launches across multiple therapeutic areas and device classifications.
Let's discuss your regulatory needs and how we can help accelerate your path to market.