510(k) Accelerator - Build expertise, submit with confidence

Challenges with 
FDA clearance

Too often, submissions get stuck because the foundation isn’t solid:

 there’s no clear structure, the narrative is scattered, the data doesn’t fully support the claims, and the language misses the mark for FDA reviewers. Without the right focus and mindset from the start, teams end up loosing time and energy that could have been avoided with a sharper strategy.

Our programs
are built
around one principle:

invest once, gain regulatory expertise for life.

You don’t just get your submission right – you gain the mindset, tools and strategies to make every future submission faster, sharper and more successful.

Master the fundamentals of FDA 510(k) submissions

For teams looking to build a solid foundation and understand the core elements of the FDA 510(k) process , empowering you to confidently navigate regulatory hurdles and lay a solid foundation for your device’s approval.

Your return
Gain the expertise to build a compliant, efficient submission process and avoid common mistakes, submission delays and high costs for preparation.

One investment, lifetime returns.

Program

• • Master the fundamentals of device positioning, classification, predicate search, verification strategy, and submission structure.
    
    
  • 5 Masterclasses covering essential topics.
    
    
  • 5 live group Q&A sessions where you get answers to your questions and learn from others’ challenges.
    
    
  • 2 individual coaching sessions for personalized guidance on your specific project.

Elevate your regulatory strategy

For teams ready to develop a tailored, strategic approach to FDA submissions, with deeper personalised support ensuring your submission is not only compliant but strategically positioned for success, so you can move through the process with confidence and speed.

Your return
 Master the process and embed best practices into your team’s way of working for years to come. Develop a customized, actionable regulatory strategy that accelerates your time to market and reduces the risk of errors.

Program

• • Everything in the Foundation mastery plan, plus:
    
    
  • 3 additional 1:1 coaching sessions focused on device positioning, predicate validation, and verification strategies.
    
    
  • Refine your regulatory strategy and ensure every part of your submission is strategically sound.

Prepare for success with full expert support

For teams who want full support and expert input during every phase of submission preparation and submission: from refining your regulatory strategy to submitting your 510(k) with confidence, knowing you have a complete, compliant submission ready for FDA clearance

Your return
This is where “invest once” truly becomes “benefit forever” — every future submission will be faster, smoother, and stronger.

Submit your FDA 510(k) with total confidence, knowing that every detail has been reviewed, every section is compliant, and your team is fully supported during the final steps of the submission process. Together, we’ll select your predicate device, compare performance data, address differences, and review key dossier sections. Together means faster, more efficient and ensuring a strong commercial position of your device and company.

Program

• • Everything in the Strategic advantage plan, plus:
    
    
  • Bi-weekly 45-minute coaching calls for deeper strategic guidance and ongoing support.
    
    
  • Full support in preparing your actual submission — review, feedback, and guidance on your 510(k) dossier.
    
    
  • Expert assistance with critical sections of your submission, including predicate device comparison, performance testing, and completeness checks.
    
    
  • Support at submission through portals like the FDA Customer Collaboration Portal or eSTAR file submission.