Start Date: 1 April 2025 | Cost: NZD 1,800 per month / NZD 5,400
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 the medical device arena, this three-month course is your golden ticket to navigating the complex regulatory landscape with ease.
The course is registered with the Regional Business Partner Network Management Capability Fund. New Zealand businesses should check to see if they are eligible for funding!
Unlock the door to medtech success
On the cusp of launching a groundbreaking medical device, but bogged down by daunting regulations? Johner Institute New Zealand, a subsidiary of the internationally acclaimed medical device regulatory consultancy Johner Institute, is here to boost your market entry. Armed with both practical and theoretical expertise, we’re ready to get your product off the ground.
Course Content
From the basics of the regulatory framework to creating a tailored strategy, this course covers it all. You’ll learn to identify key information, regularly review and adjust your strategy, and communicate effectively with your team. The goal? By the end of the course, you’ll be able to formulate a comprehensive regulatory strategy for your medical device, ready to meet the ever-changing requirements and standards.
In our Regulatory Strategy course, you will learn the following key concepts:
- Understanding the Regulatory Environment: Gain insights into the regulatory frameworks and laws that govern the medical products sector.
- Developing a Regulatory Strategy: Learn how to create a detailed and customised plan that navigates regulatory requirements effectively.
- Gathering Necessary Information: Understand the process of identifying and collecting essential data critical for strategy formulation.
- Continuous Review and Adjustment: Explore the importance of regularly updating your strategy to reflect changes in regulations or product developments.
- Enhancing Communication and Collaboration: Discover the significance of effective communication and teamwork in implementing a successful regulatory strategy.
How the Course Works
The Regulatory Strategy Accelerator Programme blends weekly two-hour group sessions with one-hour individual sessions, all hosted online via Microsoft Teams. Participants will receive useful learning materials, including comprehensive checklists, to enhance understanding and application of medtech strategy. This structured approach ensures a combination of collaborative learning and personalized guidance, enabling participants to directly apply their new knowledge to their specific professional scenarios.
Who’s This Course For?
Regulatory Affairs Managers, Product Managers and professionals responsible for ensuring that their company’s medical devices comply with regulatory requirements will find this course invaluable.
Why Every Medtech Company Needs a Regulatory Strategy
Navigating the complex terrain of medical device regulations requires a strategic approach, essential for both startups and established companies. A regulatory strategy is not just about compliance—it’s a roadmap that:
- Prevents Costly Revisions: Lacking a regulatory strategy from the outset can lead to expensive product or process modifications later. Early integration of regulatory considerations ensures that products are designed to comply from the beginning, avoiding the high costs and delays associated with post-development changes.
- Speeds Up Market Entry: For startups eager to launch their innovations swiftly, understanding regulatory paths can shave months off time to market.
- Sustains Growth for Established Companies: For those already in the market, revising regulatory strategies can facilitate expansion into new international markets and help maintain compliance as regulations evolve.
Financial Advantages of Mastering Regulatory Strategy
The cost of outsourcing regulatory strategy can be prohibitive, with fees ranging from NZD 15,000 to 35,000 per product. Our course, priced at NZD 5,400, can be paid monthly over 3 months at NZD 1,800 per month. This payment plan empowers your team to internally manage these strategies. Building this capability in-house not only enhances expertise but also saves potentially tens of thousands as you scale and extend your product lines across different markets. Repeated outsourcing for multiple products can multiply these costs significantly, making our course an investment that keeps on giving.
Early Bird Gets the Savings
Seize the chance to get your product off the ground and save some money while you’re at it. Register two months in advance and receive an exclusive 10% early bird discount. We understand how fluid the medtech industry can be, which is why we’ve introduced a hassle-free cancellation policy that allows you to cancel up to four weeks before the course starts at no cost. This worry-free registration means you can plan ahead with no financial concerns. Book early to take advantage of these savings and equip your medtech company with the regulatory insight it needs to thrive.
Course Overview Presentation
Watch our concise 5-minute presentation to learn the key facts about the course.
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At a Glance: Course Details
- Duration: 3 months, with 2 hours of group sessions per week and 1 hour of individual sessions per week.
- Cost: NZD 1,800 per month – NZD 5,400 total
- Start Date: 1 April 2025
- Time: 10:00 am -12 noon
- Location: Online via Zoom
- Capacity: Minimum 8, maximum 12 participants.
Payment
If you’d like to register for the course or have any questions, just drop us a quick note using the form. Once you’re all signed up, we’ll handle the payment through an invoice — it’s really that simple!
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We reserve the right to cancel the course if the minimum number of participants is not reached.
