At the heart of every medical startup is an innovative idea. But turning that idea into a market-ready solution requires more than innovation – it requires a clear understanding of the regulatory landscape. Johner Institute New Zealand offers targeted services designed specifically for start-ups. With our Regulatory Accelerator training programme, exclusive office hours and free educational resources, we streamline your regulatory journey and accelerate your path to market success.
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.
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.
Access free regulatory resources including webinars, blog posts, and a comprehensive starter kit. Enhance your understanding of the medical device landscape without spending a dime.
Discover how to successfully bring a medical device to market in this comprehensive 2-day introductory course by the Johner Institute New Zealand on 20 and 28 November. Designed for those…
Date: 24 April | Time: 11 AM NZT | Venue: Online via Zoom Join our online info session on 24 April at 11 am NZT to explore how our 12-month…
Here's your chance to fast-track your product's market entry with Johner Institute New Zealand's cutting-edge Regulatory Strategy Course. Designed for medtech professionals and newcomers looking to make their mark in…
Embark on a 6-month journey with Johner Institute New Zealand to master the intricacies of ISO 13485 and FDA 21 CFR 820 compliance through our Quality Management System (QMS) course,…
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!
Take control of your startup’s success with our training programme, the Medical Device Regulatory Accelerator. Designed to provide you with the knowledge and skills to navigate complex regulations, this program reduces the need for costly consulting. Book any course individually or complete them all.
Tailored for startups to master the complex medical device regulatory landscape, reducing dependency on external consultants.
Covering vital aspects from “QMS” to “Regulatory Strategy,” providing a holistic guide to end-to-end regulatory compliance.
Ensuring faster market access, informed decisions, and significant savings by avoiding expensive consultancy and regulatory missteps.
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!
Don’t miss out on the opportunity to advance your start-up with our essential seminars. By registering up to 2 months in advance, you qualify for our exclusive 10% early registration discount, ensuring you maximize your investment from the get-go. We understand the dynamic nature of start-ups, which is why we offer the flexibility to unregister at no cost up to 4 weeks before the start of the course. This risk-free registration ensures that you can plan for the future without any financial constraints holding you back. Secure your spot early to take advantage of these savings and give your MedTech venture the regulatory insight it needs to succeed.
Explore our specialized courses tailored for your startup’s regulatory success:
Accelerate your startup’s market entry with this 3-month course. Equip yourself with the tools and knowledge to formulate a robust regulatory strategy from product concept to market launch.
A 6-month immersive programme to master ISO 13485 compliance. Learn how to set up a QMS tailored to your startup, ensuring a foundation of quality and regulatory compliance.
In 5 months, understand how to collect and analyse real-world data for post-market surveillance. Learn when to conduct structured post-market Clinical Investigations for compliance and safety.
A 3-month programme focusing on clinical evaluation for pre-market submissions. Learn how to generate clinical evidence, articulate regulatory requirements and integrate these into a clinical strategy.
A 12-month course on regulatory documentation for medical software. Learn to create a Technical File for global compliance, suitable for various development roles.
Unlock your startup’s potential with our Startup-Focused Office Hours – your opportunity to get customized regulatory advice without the hefty price tag. These concise, cost-effective sessions match your pressing regulatory questions with our expert solutions.
Here’s how it works: You select a 30- or 60-minute time slot that fits your busy schedule. During that time, our specialists are at your disposal, ready to address all your questions, from compliance hurdles to market entry strategies.
The benefits for you are clear:
Say goodbye to generic advice and the endless search for reliable regulatory guidance. With our Office Hours, you get the precise support you need to make informed decisions and move your startup forward.
Ready to gain a competitive edge? Schedule your meeting today and take the first step toward regulatory mastery and market success.
Access our free resources for startups including a starter kit with essential guides and informative blog posts to navigate regulatory complexities with confidence.
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.
As of 1 July 2024, new regulations are in effect for all manufacturers offering cloud services in Germany’s healthcare sector. Providers must now present a C5 certification and meet strict…
If you plan to sell medical devices in Australia, obtaining approval from the Therapeutic Goods Administration (TGA) is a crucial step. However, if your product already has certification from a…
The introduction of the Quality Management System Regulation (QMSR) by the US Food and Drug Administration (FDA) signifies a pivotal shift for medical device manufacturers. As of February 2, 2024,…
Got questions or feedback? We’d love to hear from you — fill out the form below and we’ll be in touch soon!
