RakuOps is the operating system for ISO 13485 compliance. Instead of managing the standard in spreadsheets and binders, your team does the work in RakuOps, and that work becomes the living evidence of regulatory requirements, device quality, risk management, and controlled processes that auditors want to see.
Who needs ISO 13485
How RakuOps operationalizes the ISO 13485 clauses
Every modern ISO management system follows the same Annex SL structure. Here is how RakuOps turns each requirement into living, audit-ready evidence.
Documented information
Your SOPs, work instructions, and checklists live in RakuOps as controlled, versioned documents your team actually follows on mobile, not binders nobody opens. Every change is tracked.
Handled in RakuOpsOperational control
Run the work as enforceable digital checklists and work orders. Every step is timestamped, attributable, and impossible to skip, so the process is executed exactly as documented.
Handled in RakuOpsMonitoring and measurement
Capture inspections and readings with validation against limits, and see live dashboards and reports of what was done, by whom, and when.
Handled in RakuOpsInternal audit
Schedule and run internal audits as structured checklists with a complete, searchable evidence trail, so you walk into the audit with the records already in hand.
Handled in RakuOpsNonconformity and corrective action
Every failed check becomes a tracked corrective action with an owner and a due date, closed out with evidence, so findings never slip through the cracks.
Handled in RakuOpsManagement review and improvement
Pull the records, trends, and corrective-action history leadership needs to review the system and drive continual improvement.
Handled in RakuOpsWhat you get with RakuOps
Run production and inspection processes as controlled, attributable checklists
Capture device quality checks with validated readings
Auto-raise and track nonconformities and CAPA
Keep attributable, audit-ready device records
Audit-ready every single day
You stop preparing for audits and start being audit-ready by default. Your ISO 13485 management system runs on real work, with a complete, attributable evidence trail behind it, across every site and shift.
ISO 13485 by industry
Free ISO 13485 templates to start with
Make ISO 13485 the byproduct of how you work
Operationalize your ISO 13485 management system in RakuOps and stay audit-ready, across every standard and site. Set up in under a day, no credit card required.
Start free trialFrequently asked questions
What is ISO 13485?
ISO 13485 is the international standard for quality management systems specific to medical devices. Certification is widely required by regulators and proves you consistently meet device quality and safety requirements. RakuOps helps you operationalize and evidence the management system so you can achieve and maintain certification.
How does RakuOps help with ISO 13485 compliance?
RakuOps turns the day-to-day work the standard requires (documented procedures, operational control, monitoring, internal audit, and corrective action) into living, timestamped, attributable records, so you are always audit-ready rather than scrambling before the auditor arrives.
Does RakuOps certify my organization to ISO 13485?
No. Certification is issued by an accredited certification body after an audit. RakuOps is the software that operationalizes your management system and produces the evidence that makes passing and maintaining that audit far easier.