Regulatory Submissions

Getting your medical device to market shouldn't feel like solving a puzzle blindfolded.

At RA360, we transform complex regulatory requirements into clear pathways, guiding you through FDA, EU MDR, and global submissions with expertise that turns potential roadblocks into stepping stones.

A. Development of Regulatory Strategies

Having a comprehensive regulatory strategy is essential for understanding the resources required to bring your product to market and is particularly valuable when seeking investor funding. We develop tailored strategies based on your device's risk classification and target markets, including:

• Identifying the appropriate submission routes (510(k), De Novo, or PMA for FDA)

• Planning for EU MDR compliance and CE marking requirements

• Mapping regulatory pathways for global markets (Health Canada, AMAR, etc.)

• Conducting gap analyses to address compliance issues early

• Advising on applicable standards and clinical development plan

B. Submissions to Regulatory Authorities

When development is complete, we prepare and manage submission packages that effectively present your device's safety, performance, and compliance:

• Preparing FDA submissions (pre-submission packages, 510(k), De Novo, PMA)

• Developing Technical Documentation for CE marking under EU MDR

• Creating submission packages for Health Canada, AMAR, and other markets

• Managing communications with regulatory authorities

• Preparing responses to deficiency letters or information requests