Guides and Advice

ISO 9001 vs ISO 13485: Key Differences Explained

Leave a Comment / Authorised Representative, Blog, Client Questions, EU Regulations, EUDAMED, Guides and Advice, Medical Device Post-launch, Medical Device Pre-launch, Medical Device Validation, Quality Assurance, Quality Management, Supply Chain, UK Regulations, UK Responsible Person /

While both standards share the same DNA, they serve very different purposes. ISO 9001 is the universal language of quality management; ISO 13485 is its medical-device-specific dialect – one that speaks directly to regulators, auditors, and patients.
As the European MDR and the US FDA’s new Quality Management System Regulation (QMSR) converge, scrutiny has intensified. Every audit now tests whether a company’s medical-device quality management system (QMS) truly works or merely exists on paper.

ISO 9001 vs ISO 13485: Key Differences Explained Read More »

Mastering ISO 13485 Compliance with a Lean QMS

Mastering ISO 13485 Compliance with a Lean QMS

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In today’s medical-device sector, ISO 13485 compliance is no longer optional – it’s the ticket to market access, regulatory trust, and operational maturity.
As the European MDR and the US FDA’s new Quality Management System Regulation (QMSR) converge, scrutiny has intensified. Every audit now tests whether a company’s medical-device quality management system (QMS) truly works or merely exists on paper.

Mastering ISO 13485 Compliance with a Lean QMS Read More »

UDI and EUDAMED: Strengthen Medical Device Traceability

UDI and EUDAMED: Strengthen Medical Device Traceability

Authorised Representative, Blog, Client Questions, EU Regulations, EUDAMED, Guides and Advice, Medical Device Post-launch, Medical Device Pre-launch, Medical Device Validation, Quality Assurance, Quality Management, Supply Chain, UK Regulations, UK Responsible Person /

The alphabet soup of medical device regulation – UDI, EUDAMED, MDR – can make even the most seasoned regulatory manager twitch. But there’s no escaping it: UDI and EUDAMED are now at the heart of European medical device traceability.

UDI and EUDAMED: Strengthen Medical Device Traceability Read More »

ISO 13485 Audit Readiness: How to Pass with Confidence

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With ISO 13485 audits tightening worldwide, unprepared medical-device companies face major risks in 2025 and beyond. The regulatory climate has changed fast: global authorities are aligning standards, increasing unannounced inspections, and raising expectations of documentation quality.

ISO 13485 Audit Readiness: How to Pass with Confidence Read More »

How EU MDR Changes Impact Supply Chain Agreements

Authorised Representative, Blog, Client Questions, EU Regulations, Guides and Advice, Medical Device Post-launch, Medical Device Pre-launch, Medical Device Validation, Quality Assurance, Quality Management, Supply Chain, UK Regulations, UK Responsible Person /

The EU MDR supply chain agreement revolution has caught many medical device companies off guard. What started as a regulatory update has evolved into a comprehensive overhaul of how suppliers, distributors, and manufacturers must collaborate. If your contracts still look like they were written during the Medical Devices Directive era, you’re playing regulatory Russian roulette.

How EU MDR Changes Impact Supply Chain Agreements Read More »

CE Marking and Supply Chain Responsibilities

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When it comes to selling medical devices in Europe, most people assume that CE marking is the manufacturer’s responsibility alone. While it’s true that the manufacturer plays the lead role, distributors are not off the hook.

CE Marking and Supply Chain Responsibilities Read More »

Authorised Representative / Importer for Your Medical Device

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Expanding into the European Union (EU) or the United Kingdom (UK) is a big step for any medical device manufacturer. The markets are highly regulated — and for good reason. Patient safety, product quality, and regulatory compliance are at the core of the EU Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR), and the UK Medical Device Regulations (UK MDR).

Authorised Representative / Importer for Your Medical Device Read More »

MDR/IVDR Compliance Obligations for Importers & Distributors

Understanding Your Obligations Under MDR/IVDR

Blog, Client Questions, EU Regulations, Guides and Advice, Medical Device Post-launch, Medical Device Pre-launch, Medical Device Validation, Quality Assurance, Quality Management, UK Regulations /

Under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), compliance isn’t just the manufacturer’s responsibility. Importers, distributors, and suppliers are now considered economic operators — and that means you are legally liable for specific obligations. From verifying CE marking and language requirements to registering devices in EUDAMED and maintaining long-term traceability, your role in the supply chain is critical.

Understanding Your Obligations Under MDR/IVDR Read More »

Post‑Market Surveillance Lessons from Real‑World Audits

Blog, Client Questions, EU Regulations, Guides and Advice, Medical Device Post-launch, Medical Device Pre-launch, Medical Device Validation, Quality Assurance, Quality Management, UK Regulations /

Post-Market Surveillance (PMS) is one of the most underestimated areas of medical device compliance — yet it’s also one of the first places regulators look during an audit. Recent audits have shown a clear trend: Notified Bodies and regulators expect more than basic checklists. They want data-driven, risk-based PMS systems that prove medical devices remain safe and effective throughout their lifecycle.

Post‑Market Surveillance Lessons from Real‑World Audits Read More »

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