Assess
Targeted gap report with clause mapping, risks and a practical timeline.
ISO 13485
ISO 13485 certification support for medical device teams
Design a practical QMS, implement the right SOPs, train your team and walk into audit with evidence that stands up to inspection.
Practical QMS
SOPs and records your team can maintain
SOPs and records your team can maintain
Audit readiness
Mock audits and evidence mapped to clauses
Mock audits and evidence mapped to clauses
Risk alignment
ISO 14971 traceability into design and tests
ISO 14971 traceability into design and tests
Clean submissions
Evidence packets reviewers navigate easily
Evidence packets reviewers navigate easily
Scope
What we cover and what you receive
Choose a complete implementation or a focused workstream. Everything maps to ISO 13485 clauses and real auditor questions.
Requirements we implement
- Quality Manual and QMS scope
- Document control and records
- Design and development controls
- Purchasing, supplier evaluation, and incoming inspection
- Production and service controls
- Identification and traceability
- Risk management links to ISO 14971
- Monitoring, measurement, and post market data
- Nonconformities, CAPA, and internal audit program
- Management review and continual improvement
Deliverables you take to audit
- Gap assessment with prioritized actions and timeline
- SOP library tailored to your device and team
- Training matrix, records, and competency evidence
- Risk files with controls and traceability
- Design history file and technical documentation map
- Internal audit plan, reports, and CAPA tracking
- Mock audit findings and remediation closeout
- Submission-ready evidence packets for reviewers
How it works
From gap to certification step by step
We align activities with your device, team and markets so every hour builds audit ready evidence.
Implement
SOPs, training and risk files that match your processes with clean traceability.
Audit and approvals
Mock audit, evidence polish and support during certification or inspections.
FAQ
Common questions
How long does ISO 13485 implementation usually take?
Small teams often reach audit readiness in 10 to 18 weeks depending on device class, documentation maturity and training needs.
Can you work with existing QMS templates?
Yes. We adapt to your current documentation, repair weak points and map evidence to the standard.
Do you integrate ISO 14971 and design controls?
Yes. Risk management and design controls are linked in the QMS and visible in technical files and records.
Do you support internal audits and CAPA?
Yes. We set up an internal audit program, run mock audits and help close CAPAs ahead of certification.
Ready for ISO 13485 certification?
Book a quick call to map deliverables and dates for your device and markets.