Triskele Consulting
Empowering Medical Innovation with Strategic Consulting
At Triskele Consulting, we specialise in guiding startups and established firms in the medical device industry through complex engineering, regulatory, and quality challenges. From concept to compliance, we streamline processes, ensuring your innovations meet international standards while driving growth and success.
Why Choose
Triskele Consulting?
Proven Expertise in Medical Innovation
Triskele Consulting brings years of experience in engineering, regulatory compliance, and quality consulting, ensuring your medical device solutions meet international standards with confidence.
Tailored Solutions for Growth
We specialise in strategic consulting designed to streamline processes, accelerate approvals, and drive success, supporting startups and established firms alike.
Global Reach, Local Focus
With expertise in EU, USA, and international regulatory systems, we deliver solutions that combine global standards with localized precision to help you scale seamlessly.
Empowering Medical Devices Innovators
About Triskele Consulting
Triskele Consulting specialises in guiding medical device startups and established firms through complex regulatory, engineering, and quality challenges. With a focus on innovation and compliance, we provide tailored strategies to streamline development and approvals. Our expertise spans international markets, including the EU and USA, ensuring your products meet global standards. Whether you're launching a new device or optimising processes, Triskele Consulting is your trusted partner for success.
Triskele Consulting's Services
Triskele Consulting offers a comprehensive range of consulting services, including product development strategy, regulatory compliance, market analysis, and more. Our tailored approach ensures that startups in the medical devices industry receive the specific support they need to succeed.
Regulatory Strategy & Compliance
We provide expert guidance on navigating EU, USA, and international regulatory frameworks. From clinical investigations to submissions, we help streamline approvals and ensure compliance at every stage.
Market Readiness Support
We prepare your products for market success with tailored strategies and compliance pathways. Whether launching new devices or scaling operations, we help you move forward confidently.
Quality Systems Consulting
Our team develops and optimizes quality management systems that meet ISO standards and FDA requirements. We focus on creating scalable, compliant processes to support long-term growth.
Audit Preparation & Support
From internal audits to mock inspections, we help you identify gaps and strengthen processes. Our post-audit planning ensures fast, effective remediation and lasting compliance.
Risk Management & Documentation
We deliver comprehensive risk assessments and technical documentation to meet global regulatory standards. Our solutions simplify compliance and ensure readiness for audits and approvals.
Clinical Investigations
We help navigate the complexities of clinical investigations with confidence and clarity. Drawing on extensive experience in crafting protocols and reports for both pre- and post-market studies, we streamline the entire process. Supported by a trusted network of clinical research organizations and specialists, we ensure precision, compliance, and transparency at every stage.
