standards

ISO 13485 Certification – Medical Device Quality Management Consultancy (QMS)

Achieve regulatory compliance and patient safety with ISO 13485

ISO 13485 is the internationally recognised standard for quality management in the medical device and life sciences sector. It provides a structured framework to manage product design, manufacturing, testing, and distribution in a way that ensures safety, consistency, and traceability.

Whether you are developing a new device, expanding into new markets, or improving an existing system, ISO 13485 helps demonstrate compliance with global regulations, including UK MDR, EU MDR, and US FDA requirements.

AvISO supports manufacturers, importers, designers, and suppliers in building ISO 13485 systems that are audit-ready, risk-based, and aligned to the full device lifecycle. With support from experienced consultants and the ISOvA platform, we make complex compliance manageable.

What our clients say

“AvISO helped us rebuild our QMS to meet ISO 13485 and EU MDR requirements. Their approach was clear, focused, and tailored to our product class. With ISOvA, we now have one place to manage audits, updates, and approvals across all departments.”

Quality Director, UK MedTech Company

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How AvISO supports ISO 13485 implementation

We deliver full lifecycle support for ISO 13485 certification and compliance. Our process is structured around your product class, business model, and regulatory targets.

Gap analysis against ISO 13485 clauses and applicable regulations
Mapping roles and responsibilities across the device lifecycle
Development of quality policy, objectives, and controlled documentation
Design and development controls, including risk assessment and validation
Supplier evaluation, approval, and ongoing performance management
Training for RA, QA, and technical teams on audit expectations
Support for certification readiness, mock audits, and notified body liaison

Whether you are preparing for CE or UKCA marking, expanding into new geographies, or improving post-market controls, we provide scalable solutions with real-world clarity.

Common ISO 13485 challenges — and how we solve them

Medical device quality systems require detail, accuracy, and traceability. We help clients avoid common pitfalls:

Unclear regulatory roles or responsibilities
We clarify and document your legal obligations under UK MDR, EU MDR, or FDA rules, including manufacturer, importer, distributor, or authorised representative roles.
Incomplete or scattered documentation
ISOvA provides version-controlled templates and centralised storage for everything from risk assessments to validation reports.
Difficulty translating standards into working procedures
We write procedures with your operations in mind, avoiding generic content and ensuring audit-ready evidence at every step.
Managing complex product and supplier chains
We help you track design changes, supplier approvals, batch records, and complaint handling with clarity and precision.

Our goal is to make ISO 13485 a value driver, not just a compliance hurdle.

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Start your ISO 13485 journey with AvISO

Whether you're seeking certification for the first time or need to align your system with evolving regulations, we help you build a QMS that supports patient safety, product quality, and global compliance. With AvISO and ISOvA, complex requirements become manageable.

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ISO 13485 services from AvISO

We support organisations at every stage of the ISO 13485 journey, from initial assessment through to certification and post-market maintenance. Our support is tailored to your device type, risk classification, and market ambitions.

Expert consultancy and project delivery

Dedicated ISO 13485 consultant to guide your implementation
Full QMS development, document structure, and clause mapping
Integration of ISO 14971 and regulatory expectations
Support for CE marking, UKCA conformity, and notified body audits
Clear, fixed project timelines with agreed deliverables

System design, documentation, and lifecycle controls

Quality Manual and documented procedures tailored to your organisation
Controlled documentation for design history, technical files, and validation records
Support for IQ, OQ, and PQ requirements based on equipment and process needs
Management of nonconformance, change control, and CAPA
Complaint handling workflows and feedback integration
Storage, labelling, and distribution procedures aligned with product risk

Regulatory mapping and compliance planning

UK MDR and EU MDR alignment within ISO 13485 systems
Post-market surveillance planning and PMS reporting structure
Integration of labelling, vigilance, and field safety notice procedures
Risk management aligned to ISO 14971 and market-specific expectations
Supplier qualification, contract controls, and audit planning

Training and internal audits

Role-based training on ISO 13485 clauses and documentation needs
Senior management engagement to meet leadership and review expectations
Internal audits and mock audits to validate system effectiveness
Assistance during external audits with real-time support and evidence navigation
Post-certification check-ins to address findings and plan improvements

ISOvA for digital medical device QMS

ISOvA is our compliance platform, developed in Microsoft 365 to help you manage ISO 13485 in a way that’s live, traceable, and accessible across your teams. With ISOvA, you can:

Access centralised document libraries with version control and audit trails
Assign tasks, corrective actions, and validation updates to named individuals
Monitor nonconformities, customer feedback, and CAPA status via dashboards
Manage change control logs, approvals, and training activities in one place
Schedule reviews and retain records of audits, management reviews, and improvements
Export evidence packs and audit responses at the touch of a button

Whether you're operating across multiple product lines, sites, or jurisdictions, ISOvA ensures your QMS is visible, structured, and always audit-ready.

Integrated ISO 13485 systems for full lifecycle assurance

ISO 13485 works best when aligned with other relevant standards. We commonly integrate with:

ISO 14971 – Medical device risk management
Directly referenced in ISO 13485, this standard provides the structure for identifying and managing device-related risks across design, production, and post-market use. We help you align documentation and link risk files to design outputs and complaints.
ISO 27001 – Information security management
Medical device systems increasingly involve software, data exchange, and cloud-based monitoring. Integrating ISO 13485 with ISO 27001 ensures protection of electronic health data, traceability of access, and control over digital workflows.
ISO 9001 – Quality management systems
Many organisations already operate ISO 9001 systems for general quality control. ISO 13485 builds on this with more rigorous documentation, risk focus, and regulatory structure. Integration reduces duplication and improves business-wide maturity.
ISO 22301 – Business continuity management
Business continuity is critical for regulated organisations. Integrating ISO 13485 with ISO 22301 ensures that your critical product, service, and regulatory functions can continue during disruptions, while maintaining patient safety and traceability.
ISO 14155 – Clinical investigations for medical devices
This GCP-aligned standard is essential where clinical trials are involved. We support alignment between pre-market clinical data, post-market surveillance, and the quality system to ensure full visibility across all evidence.
ISO 14001 – Environmental management
Environmental controls are increasingly relevant, from cleanroom operations to end-of-life disposal of devices. ISO 13485 integrates well with ISO 14001 to manage waste, chemicals, energy, and supplier impacts in a structured and reportable way.

ISOvA allows you to manage all of these standards within one platform, reducing duplication and improving visibility across your risk and compliance landscape.

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Why choose AvISO for ISO 13485?

Experienced consultants with backgrounds in life sciences, digital health, diagnostics, and medical manufacturing
Strong track record supporting clients through notified body, UKAS, and global audit processes
Practical tools and templates aligned to ISO 13485, ISO 14971, and EU/UK regulations
Flexible delivery options for SMEs and enterprise clients alike
Free access to ISOvA during your first ISO 13485 project
Trusted by clients across MedTech, pharmaceuticals, biotech, and clinical sectors

Talk to us about ISO 13485 certification

Let’s explore how we can help your team — from gap analysis to digital integration.
Kent: 01892 800476 | London: 02037 458 476 | info@avisoconsultancy.co.uk

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ISO 13485 FAQs

Most frequently asked questions

What is ISO 13485 and who is it for?

It is the international standard for quality management in the medical device sector. It applies to manufacturers, importers, designers, service providers, and others in the device lifecycle.

Is ISO 13485 mandatory for CE or UKCA marking?

Not always, but it is often used as evidence of conformity. Many notified bodies require ISO 13485 certification, particularly for higher-risk devices.

How does ISO 13485 differ from ISO 9001?

ISO 13485 includes stricter requirements for regulatory documentation, risk management, validation, and traceability. It is built for the healthcare and life sciences context.

What documents are required for ISO 13485?

Your system should include a quality manual, policies, procedures, technical files, design history files, validation protocols (IQ, OQ, PQ), CAPA records, training logs, and internal audit evidence.

How long does ISO 13485 certification take?

Between 4 and 8 months in most cases, depending on product class, complexity, and current system maturity.

Does ISO 13485 cover post-market surveillance?

Yes. It includes controls for complaint handling, reporting, field safety notices, and regulatory feedback. This can be aligned with ISO 14155 or MDR requirements.

Can we integrate ISO 13485 with ISO 27001 or other systems?

Yes. We help build integrated systems that span quality, security, environment, and business continuity.

What is ISO 14971 and how does it relate?

ISO 14971 is the dedicated risk management standard for medical devices. ISO 13485 requires that your system references and aligns with it.

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Can AvISO support our team during audits?

Absolutely. We attend audits, prepare evidence packs, train teams, and support corrective actions. Our goal is to make certification smooth and efficient.

Does ISOvA support ISO 13485?

Yes. It’s built to support regulated environments and includes tools for document control, audit readiness, training, risk management, and ongoing system improvement.

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