Regulatory architecture
Qualification, classification, product code, pathway, predicate strategy, claims, evidence plan and future-change strategy.
Concept to cleared device
Software development and FDA submission in one programme.
Predetics brings software engineering, quality, clinical evidence and regulatory strategy into one programme. You avoid the gaps that appear when every workstream belongs to a different vendor.
Best suited to
Funded SaMD and AI/ML startups
Teams without an internal regulatory function
Products needing software and submission support
510(k) and De Novo programmes
Existing prototypes with documentation gaps
Platforms planning several future indications
Scope and deliverables
What the programme includes.
Every deliverable is connected to the intended use, risks and claims. We do not build the product first and attempt to reconstruct compliance afterwards.
Medical device software
Requirements, architecture, implementation and lifecycle controls designed around the actual clinical workflow and regulatory risk.
Design history file
Plans, requirements, design specifications, reviews, traceability, configuration records and verification evidence.
Risk and cybersecurity
ISO 14971 risk management, threat modelling, SBOM, security controls, testing and lifecycle documentation.
Performance evidence
Analytical, standalone, usability and clinical-performance plans and reports appropriate to the device and claims.
FDA submission and response
510(k) or De Novo authoring, eSTAR assembly, quality review, filing and support through interactive review or deficiencies.
Delivery plan
Planning and delivery.
- 01
Four-week planning
Confirm intended use, architecture, available data, likely pathway, major evidence risks, budget and programme schedule.
- 02
Build and document
Develop the software and QMS records together while closing regulatory, clinical, usability and cybersecurity workstreams.
- 03
Verify and validate
Run planned software, security, usability and performance studies against predefined acceptance criteria.
- 04
Submit and respond
Complete the marketing submission, file it with FDA and manage questions until the Agency reaches its decision.
Guarantee boundaries
What the commitment covers.
- The timeline and clearance commitment are issued only after the paid planning phase confirms that the device, data and pathway are suitable.
- The guaranteed date applies to work within the agreed Predetics scope; FDA review time is controlled by FDA.
- The programme clock pauses while required client inputs, approvals, data, access or payments are outstanding.
- Any refund or remediation terms are documented in the signed statement of work.
What we need from your team
What keeps the schedule on track.
- →Provide timely access to product owners, engineers, clinicians and decision-makers.
- →Make source code, datasets, prior documentation and vendor evidence available for review.
- →Approve intended use, claims, acceptance criteria and programme decisions on schedule.
- →Maintain adequate funding, data rights and clinical access for the agreed evidence plan.
Regulations, standards and guidance considered
21 CFR 820 / QMSRFDA 510(k)FDA De NovoIEC 62304ISO 14971IEC 62366-1FDA Cybersecurity GuidanceISO 13485
Frequently asked questions
Before we begin.
Can you start from an existing prototype?+
Yes. We assess what can be retained, what needs remediation and whether the architecture supports the intended claims. We avoid rebuilding work that already has suitable evidence.
Does the programme include clinical trials?+
We can design the evidence strategy, protocols, acceptance criteria and reports and coordinate specialist partners. Site operations, patient recruitment and wet-lab work may require separately contracted providers.
Who owns the software and documentation?+
The client owns the agreed project deliverables after payment, subject to the intellectual-property terms in the statement of work.
Can you guarantee the date of FDA clearance?+
FDA controls its review clock and may ask additional questions. After planning, we can commit to dates for work within our control and define commercial protection if scoped Predetics work causes a failure.