Clear guidance in MDR Consulting and SaMD Compliance

Bringing a medical device or SaMD to market means dealing with detailed medical devices regulations and getting your software classification right. We guide you through medical device software classification, IEC 62304, and cybersecurity — with practical support, clear documentation, and targeted training.

Your Challenges

  • Lack of Internal Expertise
    Your team isn’t specialised in medical devices regulatory consulting — making it difficult to meet UKCA, TGA, or Medsafe requirements with confidence.
  • Overwhelming Regulatory Requirements
    Navigating standards like ISO 13485, IEC 62304, and cybersecurity — especially for medical device software compliance — can be confusing and time-consuming.
  • Unstructured Documentation
    Your technical file may be incomplete or inconsistent, lacking clear medical devices classification or traceability needed for approval.
  • No Clear Market Strategy
    Requirements for SaMD classification and approval vary across the UK, Australia, and New Zealand – and many companies struggle to align with all three.

How We Help

  • Expert Consulting & Representation
    We offer practical medical devices regulatory consulting, take on PRRC/QMR roles, and act as your local representative in the UK and APAC.
  • Structured Documentation Support
    From risk management to software validation – we create and review your technical file with correct medical devices classification and region-specific structure.
  • Practical Training & Accelerator Programs
    Learn how to manage SaMD classification and software requirements with hands-on workshops and tailored training programs.
  • Scalable Regulatory Strategy
    Whether you need quick advice or full medical device software compliance support – we tailor our services to your product, team, and timeline.

How We Support You with Medical Device Regulatory & SaMD Compliance

Regulatory Consulting

Regulatory Consulting

Customized support to navigate complex regulations including UKCA (UK), TGA (Australia), and Medsafe (New Zealand). We help you with product classification, market approval strategies, and region-specific compliance roadmaps.

Technical Documentation

MDR Technical Documentation

We support the creation, review, and maintenance of technical files, risk management documentation, clinical evaluation reports, and validation plans — fully aligned with ISO 13485, UKCA, TGA, and Medsafe requirements.

SaMD & Software Compliance

SaMD & Software Compliance

We help you achieve full compliance for medical device software (SaMD) through IEC 62304, IEC 62366-1, usability engineering, and cybersecurity standards — with deep expertise in UKCA (UK), TGA (Australia), and Medsafe (New Zealand) frameworks.

External PRRC & QMR

External PRRC & QMR

We take on formal responsibilities as your Person Responsible for Regulatory Compliance (PRRC) in the UK or act as your designated Quality Management Representative (QMR) — ensuring compliance with UK-specific regulatory obligations.

In-Country Representation

In-Country Representation

We provide legal representation and regulatory liaison services in Australia (TGA), New Zealand (Medsafe), and the United Kingdom (UKCA/MHRA) — giving you local presence and streamlined communication with authorities.

Micro Consulting

Micro Consulting

Fast, flexible regulatory support tailored to the needs of medical device and SaMD companies operating in New Zealand, Australia, and the UK. Ideal for startups, scaleups, or urgent compliance blockers.

MDR Training & Programs for Medical Device & SaMD Compliance

Whether you need in-depth workshops, a structured accelerator, or just quick expert input – our Medical Devices Regulations training programs help your team stay compliant, confident, and ready for audits. Learn with real projects, practical tools, and expert guidance tailored to MDR, UKCA, TGA and more.

Explore Training & Programs

We Support Medical Device Companies in Global Markets

elevate medtech new zealand

New Zealand

Medsafe registration & regulatory strategy

elevate medtech australia

Australia

TGA approval process & in-country representation

elevate medtech united kingdom

United Kingdom

UKCA certification & MHRA support

Request Support for Your Medical Device Regulatory or SaMD Compliance

Get expert help with MDR, UKCA, TGA, or Medsafe – from classification to approval and ongoing compliance.

Stay Informed – Regulatory Insights & Compliance Trends

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Internal audits are not just a regulatory formality, they are a cornerstone of any effective quality management system. Required by international standards such as ISO 13485 and FDA’s 21 CFR Part 820.22, and expected under European regulations like MDR and IVDR, internal audits help organisations stay compliant, avoid costly errors, and continuously improve their processes.…

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Medical Software Regulatory Requirements

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May 27, 9 AM – 3 PM NZST | Location: Callaghan Innovation, Auckland | Cost: $50 Johner Institute New Zealand, in collaboration with HealthTech Activator, is hosting an interactive workshop on the regulatory requirements for medical software, including Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD). This workshop is designed…

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