JVR Compliance Consultants & Auditors
Email: info@jvrconsultancy.com Need Help? Call: 01628 56 52 56For any organisation involved in the design, development, production, installation, or servicing of medical devices, compliance with ISO 13485 is the internationally recognised benchmark for quality management.
Looking to understand how our process works and the steps to achieve your roadmap to success? Explore our Roadmap of Engagement with JVR Consultancy today!
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Whether it’s information security, environmentally friendly practices, quality management, or H&S, we can help your company achiev ISO compliance.
The most common ISO standards are ISO 9001, ISO 45001, ISO 14001, ISO 27001. In this post, we’ll be taking a look at each of these standards.
If you are interested in becoming ISO 13485 – Quality Management Systems certified, or would like to talk to one of our expert consultants simply click the following button to arrange a call back request. In a hurry, call head office today on 01628 56 52 56 and don’t forget to mention our fast track support service.
ISO 13485:2016 is the internationally recognised standard for Quality Management Systems specific to the medical device industry.
It is designed to support:
ISO 13485 is applicable to:
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While ISO 13485 is not mandatory for all medical devices in the UK, it is widely recognised and often required or strongly preferred in NHS procurement and when working with UK regulatory bodies such as the MHRA.
Key Benefits of ISO 13485 Certification:
Many NHS procurement teams will expect suppliers to hold ISO 13485 or be working towards certification as part of their due diligence process—particularly for higher-risk or connected medical devices.
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Your Compliance Challenges, Our Solutions
Why Certifications Are Essential for Your Business’s Success and Growth: At JVR Consultancy, we understand the critical challenges our clients face in today’s competitive landscape. Navigating complex compliance requirements and securing the necessary certifications can often be a barrier to growth. Whether it’s missing out on tenders due to insufficient compliance or struggling with industry-specific accreditation, these obstacles can limit your business potential.
Our tailored solutions ensure you overcome these challenges with ease. From achieving certifications to maintaining compliance and navigating audits, our expert team is here to help you gain the credentials you need—opening doors to new opportunities, winning tenders, and expanding your market reach.
Don’t let compliance be a barrier. Let it be your strength.
To gain certification, your organisation must implement a Quality Management System that meets all the requirements set out in the standard. These include:
🔍 Key Focus Areas:
The standard is designed to be flexible for organisations of all sizes, whether you’re a startup or a global manufacturer.
Achieving ISO 13485 often supports or complements other NHS and UK regulatory requirements, including:
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Achieving ISO 13485 certification can feel daunting—especially if you’re entering a new market like the UK. That’s where JVR Consultancy steps in.
Our ISO 13485 Support Services:
Whether you’re starting from scratch or upgrading an existing system, we tailor our approach to fit your organisation’s goals, size, and market strategy.
Is ISO 13485 required for UKCA marking?
Not legally, but strongly recommended. It significantly supports the quality assurance aspects of UKCA compliance and makes regulatory approval more straightforward.
Can small businesses achieve ISO 13485?
Yes. The standard is scalable and applicable to startups and SMEs, and JVR can help tailor your QMS accordingly.
How long does it take to become certified?
Typically, it can take 3–6 months, depending on the complexity of your processes and your current systems.
Becoming ISO 13485 certified is a strategic step that builds trust, ensures compliance, and unlocks opportunities with the NHS and wider UK healthcare market.
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Let’s design a quality management system that drives your business forward—compliantly, confidently, and competitively.
More reasons to choose JVR Consultancy for Compliance & Risk Management
If you’re on the verge of making the decision to improve your organisation’s quality management, don’t hesitate to reach out. Our team of experts is ready and eager to provide you with the guidance, resources, and support you need to achieve your ISO 9001 Quality Management Certification. We understand that this journey can be daunting, but with our help, you’ll have a partner every step of the way. So why not drop us a line today? Together, let’s elevate your organisation to new heights of excellence and make a lasting impact on your customers and stakeholders.
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