Medical device quality means ISO 13485. Certify it.
Renewal included
Valid 3 years
Upcoming audits
ISO 13485
ISO 13485
Audit esterno
Da pianificare
ISO 13485
ISO 13485
31/07/26
Audit interno
All audits
“Audit completato. Report caricato, solo 2 Osservazioni!”
Alessandro, Lead Auditor
OUR METHOD
This is how we get you ISO Certified.
80%
automated
Quality Management System documentation for Medical Devices generated by the platform.
5×
faster
Less waiting, less bureaucracy: from gap analysis to audit, with the same rigor required by ISO 13485..
100%
success
We prepare the ISO 13485 Audit with accredited bodies: no surprises on the day of the Audit.
quality management system for medical devices
Certify the quality of the medical devices you already design, manufacture, or distribute.
Procedure n. 5897
Stage 1 + Stage 2
Revision 02
Reviewed
WE FORMALIZE WHAT YOU ALREADY DO
We write the quality procedures for your medical devices.
We'll take care of the rest.
Production process validation, batch traceability, complaint management, and regulatory reporting: your company already manages these aspects every day. We map them, identify the requirements of the ISO 13485 standard, and build the quality management system.
Work without surprises
Your company's Medical Device Quality System monitored every day, not just during audits.
The platform monitors your quality management system in real time: validation deadlines, complaints to be closed, and supervisory reports are always under control. Maintaining your ISO 13485 becomes a routine check, not a rush every time an audit or inspection arrives.
Compliance status
Aligned with
96%
Updated in real time
2 to close
ISO 9001
Completa 100%
Attiva
ISO 14001
70%
ISO 45001
75%
ISO 27001
80%
Base HLS
70% pronto
Prepare to grow
Leverage ISO 13485 to achieve MDR compliance. And more.
The European Medical Device Regulation (MDR 2017/745) requires a compliant quality management system: ISO 13485 covers most of the requirements. Starting from here means achieving MDR compliance without rebuilding everything from scratch.
complaion's process
We'll be with you every step of the way from 0 to 13485.
Documents
Documents
3 gap
Upload documents
Let's analyze what you already have, what's missing, and what you need to be ready.
Procedura n.123
3 ready
We write procedures
We build procedures, policies, and records based on the way you actually work.
Compliant
Let's do the Audit
We carry out the Internal Audit, produce the reports and check that everything is ready.
Valid 3 years
Get the certificate
A Certification Body carries out the External Audit and issues the Certificate.
ISO 13485 CERTIFIED COMPANY
Certification issued by an Accredited Body.
Valid for 3 years
Recognized in over 170 countries
Request in public tenders
Renewal managed by us
Who has obtained ISO 13485
along with Complaion.
OFTEN COMBINED
Start from 13485, build the complete management system.
Those who already have ISO 13485 have an advantage over other standards: same structure, same Lead Auditor, same platform.
ISO 13485 cost and timelines
ISO 13485 certification: cost and timelines.
How much does ISO 13485 certification cost, and how long does it take? Both depend on your organization, and with Complaion you get a clear answer from day one.
Cost
ISO 13485 certification cost
ISO 13485 certification cost is never a fixed price list. How much ISO 13485 costs depends on company size, sites, scope, the device class and regulatory requirements, and your starting point. That is why Complaion begins with a free analysis, then prepares a tailored quote covering the Lead Auditor, the platform and the certification path.
Timelines
ISO 13485 certification timelines
ISO 13485 certification timelines vary from company to company. How long ISO 13485 takes depends on size, sites, scope, existing design, production and traceability procedures, and the resources you can dedicate. With a dedicated Lead Auditor and the Complaion platform guiding every step, timelines are significantly reduced: down to a few months, or even weeks.
FREQUENTLY ASKED QUESTIONS
Do you have any questions about ISO 13485 or how Complaion can help you?
What is ISO 13485 and why is it important for my business?
ISO 13485 is the international standard for quality management systems (QMS) specific to medical devices, ensuring that your company implements a systematic and comprehensive approach to product safety and regulatory compliance. It is essential for demonstrating your commitment to quality in global markets, enhancing customer trust, and complying with relevant regulations.
How can you help my company achieve ISO 13485 certification?
Complaion automates up to 80% of the compliance process, significantly reducing the time and effort required to achieve ISO 13485 certification. Our platform provides progress tracking and offers customizable templates to optimize your QMS implementation.
How long does it typically take to get ISO 13485 certified with Complaion?
The time to achieve ISO 13485 compliance can vary depending on the size, complexity, and readiness of your organization. However, Complaion's automation and streamlined processes can help you achieve compliance in a third of the time it would normally take, with some companies achieving compliance in just a few weeks.
What support does Complaion offer during the ISO 13485 certification process?
Complaion provides dedicated support at every stage of the compliance process. This includes guidance from a Customer Success Manager and access to in-house ISO 13485 experts who can help you navigate the certification process, ensuring you have the knowledge and resources you need for a successful compliance journey.
How can I start the ISO 13485 certification process using Complaion?
To begin your ISO 13485 certification journey with Complaion, you can request a demo on our website. This will provide you with an overview of our platform, its features, and how we can tailor our services to meet your specific needs.
Do you support certifications other than ISO 13485?
Yes, Complaion supports a wide range of certifications, including ISO 9001, ISO 27017, ISO 27018, and more. Our platform is designed to simplify certification to various standards, offering integrations and features that streamline the process based on various regulatory requirements.
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