Elevate MedTech
Elevate MedTech offers expert regulatory consulting and technical documentation for medical devices and SaMD. They specialize in navigating complex global regulations, including TGA (Australia), to accelerate market approval.
Elevate MedTech provides specialized regulatory consulting and technical documentation services for medical device and SaMD companies aiming for global market access. They offer tailored support for compliance with regulations such as TGA (Australia), UKCA (UK), and Medsafe (New Zealand), from initial product classification and strategy development to the creation of audit-ready technical files and software documentation. Their services include defining regulatory pathways, conducting gap analyses against standards like ISO 13485, and preparing regulator-ready submissions. Elevate MedTech also acts as a local sponsor for TGA applications in Australia and provides in-country representation, streamlining communication with authorities and accelerating product entry into the market. With a focus on efficiency and compliance, they help clients manage updates, respond to authority feedback, and build internal regulatory know-how through workshops and training programs. Elevate MedTech is committed to helping businesses achieve full compliance and accelerate their market approval processes.
About
**Who they are**
Elevate MedTech provides expert regulatory consulting and technical documentation services for medical devices and SaMD, specializing in navigating global regulations to accelerate market approval.
**Expertise & scope**
* Offers comprehensive regulatory consulting for medical devices and SaMD, covering classification, pathway definition, and gap analysis against standards like ISO 13485 and GSPRs.
* Develops regulator-ready technical documentation aligned with MDR, UKCA, and TGA requirements, ensuring quality system integration and audit readiness.
* Provides SaMD compliance strategies and documentation aligned with IEC 62304 and regional expectations, including threat models and software testing documentation.
* Delivers external PRRC (UK) and QMR services, managing post-market surveillance, documentation updates, and regulatory audits.
* Offers in-country representation for foreign manufacturers in the UK, Australia, and New Zealand, facilitating communication with authorities and managing regulatory obligations.
* Provides micro consulting for targeted expert input on SaMD or device classification, documentation review, and strategy development.
**Reputation / proof points**
* Expertise in navigating TGA (Australia) regulations to accelerate market approval.
* Support for compliance with MDR, UKCA, and Medsafe requirements.
* Assistance with IEC 62304, IEC 62366-1, and MDCG guidelines.
Elevate MedTech provides expert regulatory consulting and technical documentation services for medical devices and SaMD, specializing in navigating global regulations to accelerate market approval.
**Expertise & scope**
* Offers comprehensive regulatory consulting for medical devices and SaMD, covering classification, pathway definition, and gap analysis against standards like ISO 13485 and GSPRs.
* Develops regulator-ready technical documentation aligned with MDR, UKCA, and TGA requirements, ensuring quality system integration and audit readiness.
* Provides SaMD compliance strategies and documentation aligned with IEC 62304 and regional expectations, including threat models and software testing documentation.
* Delivers external PRRC (UK) and QMR services, managing post-market surveillance, documentation updates, and regulatory audits.
* Offers in-country representation for foreign manufacturers in the UK, Australia, and New Zealand, facilitating communication with authorities and managing regulatory obligations.
* Provides micro consulting for targeted expert input on SaMD or device classification, documentation review, and strategy development.
**Reputation / proof points**
* Expertise in navigating TGA (Australia) regulations to accelerate market approval.
* Support for compliance with MDR, UKCA, and Medsafe requirements.
* Assistance with IEC 62304, IEC 62366-1, and MDCG guidelines.
Additional information
Elevate MedTech's services are designed to streamline the complex regulatory landscape for medical devices and SaMD. They offer targeted support, from initial classification and documentation development to ongoing compliance and in-country representation. Their micro consulting service is particularly useful for clarifying specific regulatory questions or obtaining a second opinion on documentation and test plans. For companies without a local presence, their in-country representation and external PRRC/QMR services ensure adherence to regional obligations, including managing inquiries from authorities like the TGA and facilitating adverse event reporting. Engagement typically involves defining the scope of support needed, whether it's comprehensive documentation build, specific regulatory pathway guidance, or ongoing representation.
Key Highlights
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Offers In-Country Representation for medical devices and SaMD in Australia and New Zealand.
Source
“Your in-country partner for the UK, Australia & New Zealand”
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Provides SaMD compliance and software documentation aligned with IEC 62304 and regional expectations.
Source
“Build compliant software documentation aligned with IEC 62304 and your target region.”
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Specializes in navigating TGA (Australia) regulations for medical devices and SaMD.
Source
“Get expert help with MDR, UKCA, TGA, or Medsafe – from classification to approval and ongoing compliance.”
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Offers External PRRC & QMR services to meet regional representation requirements.
Source
“Formal appointment as PRRC (UK) or QMR for your company.”
Certifications & Trust Signals
Buyer Snapshot
Best for
- Companies seeking TGA, MDR, or UKCA regulatory consulting.
- Manufacturers needing SaMD compliance and software documentation.
- Foreign manufacturers requiring in-country representation in Australia or the UK.
How engagement typically works
- Project-based consulting for specific regulatory needs.
- Retainer-based services for ongoing compliance and representation.
- Targeted micro-consulting for quick expert advice.
Typical deliverables
- Regulatory strategy and pathway definition.
- Technical documentation files (MDR, TGA, UKCA compliant).
- SaMD compliance documentation (IEC 62304, MDCG).
- In-country representative services.
- PRRC/QMR appointment and support.
Good to know
- Best when requiring specialized expertise in medical device and SaMD regulations.
- Ideal for companies aiming for market approval in Australia, the UK, or EU.
HQ:
Sydney, AU
Languages:
English
Timezones:
Australia/Sydney
Status:
listed
Services & Capabilities
AU TGA Sponsor Services
Jurisdictions:
AU
Countries:
AU
Industries:
Medical devices, Dental
Portfolio:
1-5
Onboarding time:
5–14 days
Pricing model:
Custom pricing
Starting from:
AUD 3,500
Included services:
ARTG inclusion application preparation and submission, TGA device classification and grouping, Conformity assessment evidence mapping (EU/UK/US/CA), Annual ARTG charge reminders and continuity planning
Supports Artg:
Yes
Evidence Review:
Yes
Additional tga_sponsor_au Details
Supports Artg
Implied through TGA support and in-country representation for Australia.
Recall Vigilance Support
Mentioned in the context of PMS/PMCF obligations and adverse event reporting.
Device Classes Supported
Not explicitly stated, but services cover medical devices and SaMD which implies various classes.
