Regulatory Submissions & FDA Correspondence

• 510(k) Premarket Notifications

• Pre-Submission Meetings

• Breakthrough Device Designations

• Investigational Device Exemptions

• De Novo Reclassification Exemptions

• Enforcement Discretion Confirmation

• 513(g) Requests

• Official FDA Correspondent

Regulatory Strategy Development

• Software as a Medical Device & Digital Health

• Wearables & Remote Monitoring

• Next-Generation Medical Imaging & AI

• Antimicrobial & Infection Control Claims

• Neonatology & Perinatal Health

• Women’s Health & Urology

• Pulmonary & Respiratory Health

• Metabolic & Endocrine Health

• Neurology & Mental Health

• Rehabilitation & Assistive Devices

• Orthopedic & Implantable Devices

• Cardiovascular & Imaging

Other Services

• Clinical Trial & Biostatistics Support

• Protocol Development

• Assessment of Post-market Changes

• Ongoing Regulatory Support

• Fractional Head of Regulatory Affairs

• Comments to Proposed Rules

• Peer Reviewer