FDA strategy and Pre-Submission
FDA Strategy & Pre-Submission — 4 Weeks
A defined US pathway, predicate assessment, evidence plan and FDA Pre-Submission package.
Regulatory support for the US, Europe, Canada, UK and India
Your software works. Now let's get it cleared.
We help SaMD teams choose the right route, agree the evidence plan and prepare the software, risk, cybersecurity and clinical documentation regulators expect. If the product needs work, our developers can fix it without handing you off to another firm.
A specialist practice of Pharmadocx Consultants
Pathways and quality systems we support
US FDA
CE Marking
CDSCO India
ISO 13485
MDSAPOur solutions
Help with specific regulatory milestones.
Concept to Cleared Device
One integrated team for software, evidence and FDA submission.
Learn moreFDA Strategy & Pre-Sub in 4 Weeks
A written regulatory plan, evidence requirements and Q-Submission package.
Learn moreBreakthrough Designation in 2 Weeks
Your eligibility case, designation request and FDA filing.
Learn moreAI/ML Submission in 3 Months
A three-month 510(k) programme covering software, evidence and filing.
Learn moreFDA Hold Letter Rescue
Triage deficiencies and prepare a point-by-point FDA response.
Learn moreFDA-Ready QMS in 2 Months
QMS procedures, roles, training and initial records for SaMD teams.
Learn moreOur services
Regulatory and software services from one team.
Medical Device Software Development
Product architecture, UX, full-stack development, verification and maintenance designed around IEC 62304 from day one.
Explore serviceSoftware Regulatory Consulting
FDA 510(k), De Novo, Pre-Sub, EU MDR, CE marking and CDSCO pathways from strategy through authority review.
Explore serviceSoftware, AI & Cybersecurity Documentation
IEC 62304 lifecycle, ISO 14971 risk, clinical evidence, AI/ML documentation and FDA cybersecurity.
Explore serviceSelected clients
Healthcare teams we have worked with.
Predetics is backed by the regulatory experience of Pharmadocx Consultants, supporting medical-device teams with software development, licensing and regulatory submissions.
Why Predetics?
Software development and regulatory submissions should not happen in separate teams.
We bring both disciplines into the same room. Predetics combines medical device software engineering with the regulatory foundation of Pharmadocx Consultants, so product decisions and submission decisions support each other from the beginning.
SaMD focus
Software medical devices are our core focus—not an add-on service.
Technical depth
We work from the code, architecture, claims, hazards and evidence.
One project team
One team to design, build, document and support the submission.
Five regulatory markets
Coordinated planning for the US, EU, Canada, UK and India.
Regulatory planning
Know the pathway, evidence and budget before you commit.
We review the product, identify the likely route and set out the work your team needs to complete.
Regulatory guides
Guidance for SaMD teams.
Is Your Software a Medical Device? FDA, EU and India Compared
Read guide →FDA pathway strategy510(k) vs De Novo for SaMD: Choosing the Defensible FDA Path
Read guide →Q-Submission programmeFDA Pre-Submission Guide: Questions, Package and Realistic Timeline
Read guide →Premarket cybersecurityFDA Cybersecurity Guide: SBOM, Threat Models and Submission Evidence
Read guide →Software lifecycle evidenceIEC 62304 Documentation Guide: Build a Traceable SaMD File
Read guide →Regulatory scope