Dates: 23 July & 29 July 2025 | 17 Sept & 25 September 2025
Discover how to successfully bring a medical device to market in this comprehensive 2-day introductory course. Two separate 2-day workshops are on offer for the second half of 2025.
Ideal for start-ups, early-stage companies, and NZ manufacturers considering international markets, this training is designed for those involved in product development and sales, business owners, founders, and CEOs. The course offers an in-depth overview of implementing a quality management system (QMS) and navigating regulatory requirements.
In a Nutshell
Critical aspects of developing medical devices within a regulated environment will be explored. Attendees will learn to document product development effectively, ensuring smooth market approval. Real-world case studies will be used to delve into device qualification, classification, pre-market requirements, and post-market surveillance. Furthermore, the essential knowledge needed to make informed decisions and ensure medical devices meet regulatory standards and exceed customer expectations will be unpacked.
Johner Institute New Zealand is registered with the New Zealand Regional Business Partner Network (RBPN) Management Capability Development Fund. To find out if funding is available, businesses can inquire directly with their regional RBPN advisor. For more details visit www.regionalbusinesspartners.co.nz.
Cost: $1200 + GST per person
Time: 9 AM – 3 PM NZT online via Zoom
Learning Objectives
Businesses will understand:
- The requirements for a quality management system where an organisation must demonstrate its ability to provide medical devices that consistently meet customer and applicable regulatory requirements.
- That placement of a medical device on the market requires both the product itself and its associated documentation, based on which third parties (authorities or notified bodies) can understand the development of the product.
- The scope of the documentation, where it comes from and how it is maintained.
Attendees will gain:
- Overview of the structure of a quality management system according to ISO 13485
- Overview of the required processes and required personnel
- A case study on the qualification and classification of an MD based on the intended use of a device
- A workshop workbook
Content Overview
Day 1 (6 hours): Introduction and Regulatory Framework
- Importance of regulatory compliance in medical device development, based on real-world evidence
- Qualification and Classification using a case study of a device
- Quality Management Systems (QMS), covering ISO 9001 vs ISO 13485, process overview, & understanding of the timeframe to set up a QMS
- Pre-market Requirements, including requirements (Stakeholder – Product – Traceability), device development – verification, validation, & clinical data
Day 2 (6 hours): Detailed Exploration of Key Regulatory Aspects
- Regulatory Submission Processes – TGA/FDA/EU
- Regulatory Strategy – medical device business development
- Clinical Evidence and Performance Evaluation, covering clinical evaluation, clinical trials, & data for submission process and reimbursement
- Post-Market Surveillance and Vigilance, covering post-market monitoring related to Regulatory Strategy, adverse event reporting, & recalls and corrective actions
Summary
- Dates: 23 July & 29 July 2025 | 17 Sept & 25 September 2025
- Cost: $1200 + GST per person
- Time: 9 AM – 3 PM NZT online
- Contact: seminar@johner-institute.nz
Registration
To register, select the dates you wish to attend from the options provided and complete the linked registration form. Invoicing and confirmed registration will follow, along with answers to any questions including any around your eligibility for RBPN funding.
