ISO 13485 is the foundation of any successful medical device regulatory strategy. We help you build, implement, certify, and maintain your QMS, whether you’re a startup or an established manufacturer entering new markets.
ISO 13485 is the international standard that defines the requirements for a Quality Management System (QMS) specifically designed for the medical device industry. It is the regulatory baseline in virtually every market worldwide, and without it, you cannot sell.
Unlike ISO 9001, which covers general quality management, ISO 13485 is tailored to the specific requirements of medical device development, manufacturing, and post-market activities. It emphasises risk management, traceability, and documented processes at every stage.
Whether you’re building your QMS from scratch or preparing for your next audit, we’ve got you covered.
We assess your current QMS against ISO 13485 requirements, identify gaps, and give you a clear roadmap to certification readiness.
We build your QMS from the ground up, procedures, work instructions, forms, and records, tailored to your product and team size.
We conduct internal audits against ISO 13485, identify non-conformities, and help you close findings before your notified body visit.
In-house workshops and one-on-one training for your team, from QMS awareness to lead auditor preparation. RBP certified.
If you need an experienced Quality Manager Representative without the overhead of a full-time hire, we step in as your external QMR.
We align your ISO 13485 QMS with market-specific requirements, FDA QMSR, MDR, TGA, and UKCA, in one integrated system.
ISO 13485 is mandatory or strongly expected in virtually all major markets. The EU MDR requires it, the FDA’s QMSR (effective February 2026) aligns closely with it, TGA and Medsafe expect it, and UKCA requires a compatible QMS. In practice, you need ISO 13485 to sell medical devices globally. Typically 6,18 months depending on your starting point. If you already have quality processes in place, it can be faster. Starting from scratch, building the full QMS and passing the certification audit usually takes 12 months or more. Our gap analysis gives you a realistic timeline for your specific situation. ISO 9001 is a general quality management standard for any industry. ISO 13485 is specifically designed for medical devices and includes additional requirements around risk management, regulatory compliance, design controls, and post-market activities. ISO 13485 certification does not require ISO 9001 certification. Yes. Even if you start with one market, ISO 13485 is required or expected there too. And once your QMS is in place, expanding to additional markets becomes significantly easier, your documentation, processes, and culture are already aligned. The FDA’s Quality Management System Regulation (QMSR), effective February 2026, largely harmonises with ISO 13485. If you already have a solid ISO 13485 QMS, the additional requirements for QMSR compliance are relatively minor. We can help you assess the delta and close any gaps.