Medical Device
Regulatory Accelerator

Elevate your startup with our Medical Device Regulatory Accelerator—a training programme designed to help you navigate complex regulations and bring your device to market.

Exclusive Office Hours
for Startups

Benefit from exclusive office hours tailored just for startups. Get the bespoke regulatory advice you need, at startup-friendly rates, to accelerate your path to commercialization.

Learn How to Launch Your Medical Device

Pave the way to commercial success with our targeted offerings designed specifically for startups. Our cornerstone is the Medical Device Regulatory Accelerator, a training programme that includes courses of 3, 5, and 6 months, equipping you with the critical insight and tools you need to navigate regulations and get your device to market. For bespoke advice, our dedicated online office hours allow you to ask questions at start-up-friendly rates. Complementing these services, our free learning materials – including webinars, blog posts and a starter kit – give you a comprehensive understanding of the field.

Turn your innovative idea into a compliant, market-ready success. Let’s get started!

Comprehensive
Training

Tailored for startups to master the complex medical device regulatory landscape, reducing dependency on external consultants.

Holistic
Regulatory Roadmap

Covering vital aspects from “QMS” to “Regulatory Strategy,” providing a holistic guide to end-to-end regulatory compliance.

Accelerate Your Regulatory Expertise
in as Little as 3 Months

Unlock unparalleled value with our Medical Device Regulatory Accelerator, an investment in your start-up’s long-term success. Comprising diverse course structures, we offer a 6-month programme in Quality Management System (QMS) and Product Documentation for SaMD, and a shorter but intensive 3-5 month curriculum in Regulatory and Clinical Strategy. Each course has a limited number of places to ensure personalised guidance.

Why choose us? Our practical approach includes weekly one-hour online sessions combined with invaluable face-to-face meetings that can be adapted to suit your environment. Ideal for healthcare professionals, regulatory affairs experts and startup executives, the programme gives you the practical skills to independently set up a QMS, develop clinical and regulatory strategies, and identify when and what type of clinical evidence is required for market entry.

We also offer startup-specific workshops on topics such as risk management and cybersecurity, coupled with consultancy services tailored to your specific needs. With minimum subscriptions as low as five participants, we provide flexibility without compromising quality. Enrol now and steer your startup towards regulatory excellence!

Starter-Kit

Discover our free starter kit, carefully crafted for start-ups venturing into regulatory waters. This invaluable ebook provides you with key insights and tools to navigate the complex world of regulations. It is packed with easy-to-digest guides and checklists that will enable you to tackle regulatory challenges with confidence and ease.