Quality system architecture
Quality manual, policy, organisation, process map, responsibilities, document hierarchy and controlled templates.
FDA-ready QMS
SaMD quality system implementation in two months.
Build the controls your team actually needs to develop, release and maintain medical device software—without filling a library with procedures nobody follows.
Best suited to
First-time SaMD manufacturers
Startups preparing a 510(k) or De Novo
Teams moving out of prototype development
Companies replacing generic templates
Software teams preparing for ISO 13485
Organisations aligning to FDA QMSR
Scope and deliverables
What we implement.
The system is configured around your organisation, product lifecycle, suppliers and regulatory markets—not copied from a hardware manufacturer.
Design and software controls
Planning, inputs, outputs, reviews, traceability, verification, validation, configuration, release and change control.
Risk and usability
Integrated product risk, cybersecurity risk and usability engineering processes connected to design and post-market work.
Operational quality
Document control, training, supplier qualification, nonconformance, CAPA, complaint and feedback procedures.
Management oversight
Quality objectives, metrics, management review, internal audit planning and escalation responsibilities.
Initial implementation records
Training evidence, approved supplier records, project plans, design records and a roadmap for remaining audit-readiness work.
Delivery plan
Eight-week implementation schedule.
- 01
Weeks 1–2 · Design
Confirm markets, products, organisation, tools and process owners; complete gap assessment and QMS architecture.
- 02
Weeks 3–4 · Configure
Draft and configure core procedures, templates, roles, workflows, approvals and electronic QMS controls.
- 03
Weeks 5–6 · Implement
Train process owners, migrate priority records and begin using the system on the active medical device programme.
- 04
Weeks 7–8 · Stabilise
Review implementation evidence, correct gaps, establish metrics and issue the audit and certification readiness roadmap.
Guarantee boundaries
What the commitment covers.
- Two months covers implementation of the agreed core QMS scope, not ISO 13485 certification or an external audit outcome.
- The client must nominate process owners, attend training and approve procedures and records within the agreed schedule.
- Complex multi-site operations, legacy remediation and additional jurisdictions may require an expanded scope.
- Readiness, support and commercial remedies are defined against objective deliverables in the statement of work.
What we need from your team
What keeps the schedule on track.
- →Appoint a management representative and accountable owners for each implemented process.
- →Provide organisation, supplier, product, tool and existing-procedure information at kickoff.
- →Review and approve procedures promptly and ensure relevant staff complete training.
- →Use the implemented system to create genuine records rather than treating approval as the end of adoption.
Regulations, standards and guidance considered
FDA QMSR21 CFR Part 11ISO 13485:2016IEC 62304ISO 14971IEC 62366-1FDA Cybersecurity GuidanceMDSAP
Frequently asked questions
Before we begin.
Will we be ISO 13485 certified after two months?+
No. Predetics implements the agreed QMS baseline in two months. Certification requires operating records, internal audit, management review and a successful independent registrar audit.
Does an FDA submission require ISO 13485 certification?+
Not necessarily. The applicable requirement depends on market and device context, but the manufacturer must operate appropriate quality controls and maintain credible design and production records.
Can you configure our electronic QMS platform?+
Yes. We can help select and configure a suitable platform or work within an existing system, provided its controls support the agreed processes.
Do you provide ongoing quality support?+
Yes. After implementation, support can cover internal audits, management review, CAPA, supplier controls, complaints, design changes and post-market activities.