Quality
ISO 13485 is the international standard for medical device quality management systems - and the backbone of compliance in almost every market. UK MDR, EU MDR and IVDR, the FDA's Quality Management System Regulation (QMSR), Australia's TGA and UAE registration all expect a QMS built to ISO 13485.
At Taylored Consultancy Ltd, we make ISO 13485 clear and practical. We build, audit and improve device quality systems with support from experienced lead auditors, so you're certification-ready and inspection-ready - never scrambling.
Clearing the path to market -
regulatory and quality expertise that gets your medical device quality systems certified, compliant, and trusted.
We develop and implement a complete ISO 13485 quality management system tailored to your device, your processes and the markets you sell into.
Already certified, or part-way there? We run a full gap analysis or pre-audit health check to find and fix weaknesses before they become findings.
We help you put compliant design control, risk and technical documentation in place - the records auditors and Notified Bodies scrutinise most.
We weave ISO 14971 risk management through your QMS so risk isn't a bolt-on, but part of how you work.
We conduct internal audits against ISO 13485 and your applicable regulations, preparing you for external inspections and audits.
We help you build effective corrective and preventive action processes that satisfy auditors and genuinely improve your operations.
We carry out supplier and sub-contractor audits so you have confidence in your supply chain and the evidence to prove it.
We map your ISO 13485 system against EU MDR/IVDR, the FDA QMSR and MDSAP, so one well-built system satisfies multiple regulators at once.
Facing a certification body, Notified Body or FDA inspection? We provide hands-on support to help you prepare, respond and stay compliant.
A quality system shouldn't just sit in a drawer gathering dust. We build practical systems your team actually uses, so you're covered, certified, and audit-ready - without unnecessary delays or surprises.
ISO 13485 - Medical devices quality management systems
ISO 14971 - Risk management for medical devices
EN 62304 / IEC 62304 - Medical device software lifecycle
ISO 19011 - Auditing management systems
ISO/IEC 17021 - Requirements for certification bodies
EU MDR (2017/745) / IVDR (2017/746) - QMS obligations
FDA QMSR (21 CFR 820) - US device quality system regulation
MDSAP - Medical Device Single Audit Programme
ISO 9001 - General quality management
IEC 62366 - Usability Engineering
