Embark on a 3-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, part of the Medical Device Accelerator programme. This immersive course is your blueprint for establishing a QMS that not only meets, but exceeds the standards of quality and regulatory compliance for your organisation. New Zealand businesses may be eligible for funding through the Regional Business Partner Network!
Tailoring Excellence in MedTech
Are you preparing to launch an innovative medical device, but daunted by the complex web of regulatory requirements? The Johner Institute New Zealand, backed by the global reputation of the Johner Institute’s medical device regulatory consultancy, is pleased to launch a series of seminars tailor-made for professionals looking to carve out their niche in the medical device sector. We bring a blend of practical application and theoretical insight to help propel your product forward.
Course Content Designed for Impact
This 3-month course has been carefully designed to guide professionals through the development of a comprehensive QMS in accordance with ISO 13485 and FDA 21 CFR 820. Through a combination of interactive sessions, practical exercises and individualised guidance, participants will gain the ability to interpret, apply and adapt these standards to their organisation’s unique context.
Course Highlights
- Introduction to Quality Management Systems: A deep dive into the essentials of ISO 13485 and FDA 21 CFR 820.
- Hands-on QMS Development: A step-by-step guide to building a compliant QMS.
- Customisation for Your Organisation: Techniques for tailoring the QMS to the specific needs of your organisation.
- Documentation Mastery: Skills for creating and maintaining critical documentation.
- Ensuring Compliance: Insight into interpreting standards to ensure compliance.
- Audit and Enhancement Strategies: Tactics for conducting internal audits and promoting continuous improvement of your QMS.
Who Will Benefit?
This course is designed for professionals, managers and staff within the medical device and technology sectors who want a comprehensive understanding of how to implement and refine Quality Management Systems within their organisations.
Course Outcome
Participants will be able to interpret the requirements of ISO 13485 and FDA 21 CFR 820, establish and adapt a QMS for their organisation, and ensure that it meets both regulatory standards and company-specific requirements. Plus, they will save money by eliminating the need for costly external consultants.
Funding Available
We are registered with the Management Capability Development Fund. New Zealand companies may be eligible for funding. Find out more by visiting www.regionalbusinesspartners.co.nz.
Secure Your Advantage with Early Bird and Risk-Free Registration
Seize the opportunity to strengthen your organisation with this essential course. By registering up to two months in advance, you will receive a 10% early bird discount, allowing you to optimise your investment from the outset. Recognising the transient nature of the medtech industry, we offer the option of withdrawing up to 4 weeks before the course starts, with no financial penalty. This flexible enrolment process allows you to plan ahead with confidence and financial peace of mind. Book early to take advantage of these benefits and give your organisation the quality assurance it deserves.
Course Overview Presentation
Watch our concise 4-minute presentation to learn the key facts about the course.
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Course Logistics:
- Duration: 3 months, with 2 hours of group study and 1 hour of individual study per week.
- Cost: NZD 1,800 per month – NZD 5,400 total
- Start Date: Wednesday, 12 March 2025
- Location: Online via Zoom
- Capacity: Minimum 8, maximum 20 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!
Submit Your Inquiry or Request an Invoice
We reserve the right to cancel the course if the minimum number of participants is not reached.
