Our Services

We support companies in successfully bringing safe, effective, and compliant devices to market. Our role blends technical expertise, regulatory knowledge, project oversight, and industry insight to streamline development and approval.

Regulatory Strategy
A person is holding a tablet device displaying a digital rendering of a leg with a white medical cast. In the background, there is a medical examination table and glass panels with red stripes.
A person is holding a tablet device displaying a digital rendering of a leg with a white medical cast. In the background, there is a medical examination table and glass panels with red stripes.

We make sure your medical device meets all compliance requirements with the TGA in Australia and Medsafe in New Zealand, while also aligning with international standards market

A vintage typewriter holds a sheet of paper with the words 'WELLNESS TECH' typed in large, bold letters. The typewriter is in a shade of olive green, with a focus on the metal and mechanical components. The paper is placed neatly in the roller, ready for typing more text.
A vintage typewriter holds a sheet of paper with the words 'WELLNESS TECH' typed in large, bold letters. The typewriter is in a shade of olive green, with a focus on the metal and mechanical components. The paper is placed neatly in the roller, ready for typing more text.
A person in medical attire stands in a room viewed through partially open double doors, numbered 3. The setting appears clinical, with a neutral color palette and a tiled ceiling. The person seems to be preparing or handling medical equipment or materials.
A person in medical attire stands in a room viewed through partially open double doors, numbered 3. The setting appears clinical, with a neutral color palette and a tiled ceiling. The person seems to be preparing or handling medical equipment or materials.
Clinical Support

We support the planning and management of clinical trials, ensuring devices are tested for safety and performance, and assist with preparing regulatory submissions for approval.

We work with clients to evaluate user needs, market trends, and competitor products. This insight allows us to guide informed decision-making and identify clear opportunities for success.

Commercialization Strategy

We support the full product development journey — from generating and validating ideas to designing and prototyping solutions that are practical, compliant, and cost-effective. Through continuous testing and refinement, we ensure your device evolves to meet user needs, quality standards, and market expectation

Product Development and Design

We help you navigate the regulatory requirements for custom-made medical devices, ensuring compliance with TGA and Medsafe standards. Our support covers documentation, record-keeping, and post-market obligations, giving you confidence that your devices are safe, compliant, and ready for clinical use

Custom-Made Medical Devices

We help identify and manage risks throughout the product lifecycle, ensuring compliance with standards such as ISO 14971. Our approach minimises safety and regulatory risks, giving you confidence in both compliance and market readiness

Risk Management

Frequently Asked Questions

What services do you offer?

We provide strategic guidance and support throughout the medtech lifecycle.

Who are your consultants?

Our team consists of industry veterans with decades of experience in biomedical consultancy and medical technology.

How do you ensure success?

We integrate regulatory, clinical, and commercial strategies from the beginning to maximize your venture's potential.

What is your approach?

We take a holistic approach, focusing on the big picture for effective medtech solutions.

How can I contact you?

You can reach us through our contact page for inquiries and support.

Our Projects

Explore our successful medtech consultancy projects and partnerships.

A prominently displayed sign with the name 'sanofi' is illuminated against a purple background. The sign seems to be part of an exhibition or conference setup, with multiple spotlights hanging from the ceiling.
A prominently displayed sign with the name 'sanofi' is illuminated against a purple background. The sign seems to be part of an exhibition or conference setup, with multiple spotlights hanging from the ceiling.
Regulatory Strategy

Navigating compliance for successful market entry.

A laboratory machine with a protective transparent cover is positioned on a counter. Next to it, a monitor is attached, and various cables are connected. The setting appears to be sterile, with a focus on technology and instrumentation.
A laboratory machine with a protective transparent cover is positioned on a counter. Next to it, a monitor is attached, and various cables are connected. The setting appears to be sterile, with a focus on technology and instrumentation.
Two women are engaged in conversation in a medical setting, one wearing a white coat, suggesting she is a healthcare professional. The environment contains medical equipment, possibly indicating a check-up or consultation is taking place.
Two women are engaged in conversation in a medical setting, one wearing a white coat, suggesting she is a healthcare professional. The environment contains medical equipment, possibly indicating a check-up or consultation is taking place.
A person is undergoing a medical scan inside an MRI machine, with another individual assisting by adjusting their position. The scene appears clinical, with the MRI machine's interior emitting a soft pink glow. The assistant is wearing a blue checkered shirt and a white apron.
A person is undergoing a medical scan inside an MRI machine, with another individual assisting by adjusting their position. The scene appears clinical, with the MRI machine's interior emitting a soft pink glow. The assistant is wearing a blue checkered shirt and a white apron.
Clinical Trials

Expert guidance through every phase of clinical development.

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info@corelineconsulting.org

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