Built from inside regulated business.
Bespoke Quality Solutions is a Queensland-based quality and regulatory consultancy working with medical device companies, NDIS providers and research organisations. We build quality management systems, prepare organisations for audit and certification, and provide interim quality and regulatory leadership. Every system is sized to the business and handed over so your team can run it.
What we believe about quality
Fit the system to the business.
A five-person start-up needs a QMS built for five people. We’ll show you the smallest system that passes audit and still helps you run the business.
Your team should own it.
We coach while we build, so your people understand the why. When we step back, the system keeps working.
Stay calm at audit.
We have prepared for and hosted TGA inspections and NDIS audits. Good preparation turns audit day into a conversation.
The founder
Dave Tiernan, Principal Consultant
Dave founded Bespoke Quality Solutions after more than 15 years in quality, regulatory and operations roles across medical devices, pharmaceuticals and diagnostics, in organisations ranging from global manufacturers to start-ups.
He has hosted TGA onsite inspections, delivered MDSAP certification, taken Class III devices through to market and integrated multiple businesses onto one site after an acquisition. He is an ISO 13485 Lead Auditor and holds a BSc (Hons) in Biomedical and Advanced Materials.
Book 20 minutes.
Tell us where you are and where you need to get to. If we’re not the right fit, we’ll tell you who is.
Noosa Heads, Queensland
0420 548 781 · info@bespokeqs.com · LinkedIn