Home/ISO Certification/ISO 13485
ISO 13485 Certification,
For Medical Device Manufacturers
We help device manufacturers, contract manufacturers and their suppliers build an ISO 13485 quality management system that holds up in a certification audit and lines up with what FDA now expects — design controls, risk management, production and post-market activity in one system, documented once and used daily.
- A division of Liberty Management Group Ltd — established 2009
- Aurora, IL · Greater Chicago
- Submission-ready documentation
- On-time delivery
One Device Quality System, Two Audiences
What ISO 13485 requires
ISO 13485 takes the management system idea and puts regulatory obligation at the centre of it. Risk management runs through every process, documentation requirements are explicit, and design controls, traceability and post-market feedback carry weight a general standard does not give them. For US manufacturers it also matters that FDA’s Quality Management System Regulation now incorporates ISO 13485 by reference, so one system can answer to a certification body and to an FDA investigator.
- Design and development controls, design history and transfer
- Risk management across the product lifecycle
- Purchasing controls and supplier evaluation
- Production, process validation and traceability
- Complaints, CAPA and post-market surveillance
From gap analysis to certification
We start from what you already have — procedures, device files, whatever the last audit left behind — and map it against ISO 13485 and, where it applies, 21 CFR Part 820 as amended. The result is a system your team can run without a consultant on retainer, and a documented trail that answers the questions an auditor or an investigator actually asks.
- Gap analysis against ISO 13485 and FDA QMSR alignment
- Quality manual, procedures and records structure
- Design control and risk management files
- Internal audit programme, management review and CAPA
- Support through Stage 1 and Stage 2 certification audits
ISO 13485 or ISO 9001?
If you design, manufacture or supply components for medical devices, ISO 13485 is the standard your customers and regulators expect, and ISO 9001 will not substitute for it. Holding both is rarely necessary. Suppliers outside the device chain are sometimes asked for 13485 by a single customer, which is worth a conversation before you commit to the scope and the annual audit cost. Liberty Compliance Solutions is part of Liberty Management Group, which has worked on FDA submissions and device compliance since 2009, so the certification and the regulatory pathway can be looked at together.
More ISO Consulting from Liberty Compliance
Need Help with Compliance?
Our experts are ready to help you navigate regulatory requirements and achieve your certification goals.
Tell us about your devices and where you are with ISO 13485, and we will reply within one business day.
Experienced Experts
Hands-on experience in regulatory compliance and management systems.
Tailored Solutions
Solutions that fit your business, industry, and product requirements.
On-Time Delivery
Efficient and reliable service to help you meet your business deadlines.