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 involved in product development and sales, business owners, founders, and CEOs, this course offers an in-depth overview of implementing a quality management system (QMS) and navigating regulatory requirements.
Ideal for start-ups, early-stage companies, and NZ manufacturers considering international markets, this training ensures you understand the critical aspects of developing medical devices within a regulated environment. You will learn to document product development effectively, ensuring smooth market approval. With real-world case studies, the course covers device qualification, classification, pre-market requirements, and post-market surveillance. Attendees will gain the essential knowledge needed to make informed decisions and ensure their medical devices meet regulatory standards and exceed customer expectations.
Johner Institute New Zealand is registered with the Management Capability Development Fund offered through the Regional Business Partner Network (RBPN). To find out if funding is available, businesses can inquire directly with their regional RBPN partner. For more details, visit www.regionalbusinesspartners.co.nz.
If you are not yet part of the network, please contact us at: seminar@johner-institute.nz.
Find out more about the RBPN
Cost: $1200 + GST per person
Time: 9 AM – 3 PM NZT online
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 – Workshop 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 – Workshop 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
KEY FACTS
- Dates: 20 & 28 November
- Cost: $1200 + GST per person
- Time: 9 AM – 3 PM NZT online
- Contact: seminar@johner-institute.nz
Elevate your approach to medical device development with expert insights and practical knowledge. Secure your spot today!
REGISTRATION
To register for the course, use the form below, or contact us at: seminar@johner-institute.nz.
