Services

Review services to learn what may work best for you and your team. Wondering about something not listed here? Your curiosity is welcome! Complete the contact form to start a conversation.

Regulatory Intelligence Consulting

Retainer or ad hoc hourly support on regulatory intelligence for your specific product and business needs. Option for virtual presentations.

Expertise in U.S. medical device regulations.

Customized Training (Virtual)

Individual or team training on medical device fundamentals. Tailored to your company needs. Example topics include:

  • Device Classification

  • Preparing a comprehensive 510(k)

  • Troubleshooting deficiencies

Regulatory Strategy Development

Retainer or ad hoc hourly support on regulatory strategy development. May include:

  • Written regulatory strategy

  • Walkthrough of special considerations and additional resources

  • Planning sessions

Contact us

Interested in working together? Fill out some info and we will be in touch shortly. We can’t wait to hear from you!