2 Capabilities

2.1 Design and Development

Innovation is what we do. We're dedicated to empowering your vision, fostering a future of improved health and wellbeing through your groundbreaking medical devices.

2.1.1 Concept Development

Let’s start at the very beginning. We work closely with startups to strengthen IP and create product solutions that are a perfect fit for your customers, users, and your business.

2.1.2 Prototyping

We have extensive prototyping know-how to validate your product at every stage of the development journey. From quick mock-ups, through to production-ready samples.

2.1.3 Product Visualisation

Show don’t tell. Sometimes you’ve really got to sell the idea. We can produce stunning product visuals to bring your next pitch or marketing campaign to life.

2.2 Regulatory and Quality Support

We take challenging medical device compliance and transform it into a strategic asset. From ideation and product registration to post-market compliance, our deep understanding of the regulatory landscape will help guide you through every step. We have the capability to provide end-to-end regulatory support for your medical devices. Our service includes but is not limited to:

2.2.1 Regulatory Strategy

We tailor regulatory strategies that align with your business objectives. Our strategies will guide your medical device through the complex regulations of global markets, including Australia, the United States, and the European Union.

2.2.2 Quality Management System Development

Our Quality Management System (QMS) development services focus on embedding quality into your organization's DNA. Our QMS systems promote continuous improvement, ensure compliance, and drive sustainable success in the medical device industry.

2.2.3 Technical File and 510(k) Development

Our expertise in Technical File and 510(k) development ensures your product documentation is comprehensive, clear, and compliant. Our dossiers effectively demonstrate the safety and performance of your medical device to regulatory authorities.

2.2.4 Clinical Evaluation Reports

A critical step in gaining market approval, our Clinical Evaluation Reports (CER) help you consolidate scientific evidence to demonstrate the clinical safety and performance of your device.

2.2.5 Clinical Study Support

If you need to conduct a clinical study, we can help you prepare a comprehensive and regulatory-compliant technical dossier tailored to your requirements. We will work closely with your CRO to ensure your application is thorough, well-structured, and submission ready.

2.3 Pre-clinical Testing

Preclinical testing is essential for demonstrating the safety and performance of your medical device. We can support a wide range of preclinical testing requirements, covering the majority, if not all, of your testing needs.

2.3.1 Mechanical Testing

Many devices require rigorous mechanical testing to ensure strength and safety. We have a range of in-house mechanical testing services, including static/dynamic compression testing, static/dynamic tensile testing, and static torsion testing.

2.3.2 Biocompatibility Testing

Devices that come into direct or indirect contact with patients or users require a comprehensive biocompatibility evaluation. In collaboration with our trusted partner labs, we offer comprehensive biological evaluation and testing services to ensure your device meets biocompatibility requirements.

2.4 Process Validation and Verification

Process validation or verification is fundamental to ensuring the quality, safety, and consistency of your medical device. We can support you in the validation of cleaning and sterilisation, packaging and transport, shelf life, and other key manufacturing processes.

2.5 Manufacturing

With an extensive network of local and global manufacturing partners, we can connect you to and collaborate with the right people to make your product a reality.

Contact:
info@titanmed.tech

LinkedIn:
Titan Medical