Medical device compliance is rarely the problem in theory. The challenge is making ISO 13485 and regulatory requirements work in real companies, with real products, limited time, and competing priorities.
That’s exactly why we’ve launched Quality and Regulatory Compliance for Medical Device Manufacturers, a tailored, one-on-one training service designed to build practical, audit-ready capability inside your organisation. The service has been approved by the Regional Business Partner (RBP) Network, making it eligible for management capability development funding.
What the service focuses on
The training is built around your actual devices, markets, and processes. Together, we work through:
- Applying ISO 13485 requirements across the full product lifecycle
- Identifying the regulatory requirements relevant to your target markets (e.g. Australia, EU, US)
- Strengthening your quality management system in areas such as risk management, design control, supplier management, change control, and complaint handling
- Creating and updating the documents auditors and regulators actually expect to see.
The outcome is tangible: updated procedures, clearer regulatory alignment, a documented gap assessment, and a prioritised implementation roadmap you can realistically execute.
How the training is delivered
The programme is delivered one-on-one for business owners or responsible managers. Depending on your needs, sessions can be run:
- In person
- Online via Zoom
- On-site at your facility
This format allows us to go deep into your specific challenges and make progress where it matters, rather than talking in abstractions.
Funding support through the RBP Network
As an RBP-approved service, eligible New Zealand businesses may receive up to 50% co-funding, to a maximum of $5,000 (excluding GST) per financial year, through the Management Capability Development Fund.
Funding is allocated by an RBP Growth Advisor and depends on eligibility and availability. To access it, businesses need to register with the Regional Business Partner Network and complete a discovery session with an advisor.
Who this service is for
This service is suited to medical device manufacturers who want to:
- Strengthen compliance without overengineering their QMS
- Prepare for audits, certifications, or market expansion
- Move from reactive compliance to a controlled, well-documented system
If you’re serious about building compliance capability that stands up to scrutiny — and actually supports your business — this programme is designed for you.
Register
Book your place in the Quality and Regulatory Compliance for Medical Device Manufacturers programme by contacting us at info@elevate-med.tech or via our contact form.
