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ISO 13485

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What is ISO 13485 - The Medical Device Management System?

Increase trust. Reduce risk. Win more contracts.

At each stage of a product’s life cycle, processes and practices are scrutinised against the 13485 standard and regulatory requirements (depending on the products and services in question).

  • Design
  • Manufacture
  • Assembly
  • Testing
  • Packaging
  • Storage
  • Delivery
  • Any service stages

Each of the processes required to deliver products and services to your clients will need to be documented in a quality management system (QMS) in order to demonstrate regulatory compliance and best practice.

We make ISO 13485 certification smooth, structured, and stress‑free – whether you’re scaling a start-up or enhancing a mature QMS.

Why ISO 13485 matters

If you operate in the medical device supply chain, you already know that quality isn’t optional – it’s everything. ISO 13485 is the global benchmark for safety, consistency, and regulatory compliance.

ISO 13485 opens doors to new markets, strengthens customer confidence, and future‑proofs your operation.

We help you get there without drowning in documents or losing weeks of productivity.

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What you can expect from us

  • Clear, jargon free guidance

    Complex requirements translated into practical steps.

  • Documentation built around how you already work

    Not templates. Not bureaucracy. A useful quality system that people actually follow.

  • End to end support through audits

    From gap analysis to final assessment — we stand with you all the way.

What we deliver

  • Complete ISO 13485 QMS development
  • Risk and design‑control guidance
  • Supplier and traceability management systems
  • Internal audit programmes
  • Staff training & audit readiness
  • Ongoing support for continuous improvement

Perfect for

  • Manufacturers
  • Distributors
  • Component suppliers
  • Sterilisation services
  • Software as a Medical Device (SaMD)

Whether you’re seeking CE marking, MHRA compliance, or entering global markets, ISO 13485 is the backbone of your journey.

How Can Statius Help?

ISO certification enhances efficiency, ensures regulatory compliance, and strengthens credibility. An experienced consultant simplifies the process, delivering long-term value beyond certification. The right consultant helps businesses implement systems that support sustained success.

For professional consultancy services tailored to any size company, contact our team for professional expert advice today.

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