Implementation of your ISO 13485 Quality Management System, ready for audit
We design and implement your QMS under ISO 13485 end to end: documentation, processes and records that withstand an audit and enable market access.
ISO 13485 is no longer optional for the US market
Since February 2, 2026, the FDA replaced the former Quality System Regulation (21 CFR Part 820) with the Quality Management System Regulation (QMSR), which incorporates ISO 13485:2016 by reference. In practice, the standard that was already the basis for access to Argentina, Brazil and the European Union is now also the basis for compliance in the United States. A single well-designed quality system serves all four markets.
What it includes
- Gap analysis against ISO 13485:2016 and the additional QMSR requirements.
- Quality manual, policy and objectives, process map.
- Procedures (SOPs) and records adapted to your actual operation, not generic templates.
- Risk management integrated into the QMS, per ISO 14971.
- Document and record control, with traceability and 21 CFR Part 11 readiness.
- CAPA, supplier control, nonconformity management and internal audits.
- Preparation for the certification audit and support during it.
Our own accelerator for document control
For the documentary core of the system we work with DocQMS Regulado, a document control solution built on the requirements of ISO 13485, FDA QMSR, CE/EU MDR, ANVISA and ANMAT, with a focus on 21 CFR Part 11 readiness. It lets you set up the documentation base with traceability from day one.
How we work
Diagnosis
We survey your operation and measure the gap against the standard.
Design
We define the documentation architecture and processes tailored to your company.
Implementation
We write procedures, train your team and put the system into operation.
Audit preparation
We run an internal audit and support you through to certification.
Frequently asked questions
How long does it take to implement ISO 13485?
It depends on company size, product complexity and how mature the current system is. After the initial diagnosis we give you a concrete schedule with milestones.
With ISO 13485, am I already FDA compliant?
The QMSR incorporates ISO 13485:2016 but adds FDA-specific requirements. We design the system to cover the standard and those additional requirements, so it serves all four markets.
Do you issue the certification?
No, and it is important that we do not: certification is granted by an accredited, independent certification body. We implement the system, prepare you for the audit and support you during it.
Does the same system work for MDSAP?
ISO 13485 is the basis of MDSAP. If your goal includes several markets under that scheme, we design the system with it in mind from the start.
You may also need
ISO 14971 risk management
The risk management file your dossier requires in any jurisdiction.
View service ComplyMedical device registration and approval
Strategy and management of your device registration with ANMAT, ANVISA, FDA and CE, coordinated in a single base dossier.
View service ComplyRegulatory affairs and ongoing compliance
Renewals, change management and post-market surveillance to keep your product current.
View serviceWhere does your quality system stand against ISO 13485?
Request a diagnosis of your situation. We return a concrete read of gaps and next steps.