Quality systems sized to your business.
I'm Dave Tiernan. I've hosted a TGA onsite audit, passed an NDIS audit and taken Class III devices through submission. I help start-ups, multinationals and universities build quality systems their teams can run.
I've been on your side of the audit table.
Onsite TGA inspection, prepared, hosted and passed as Enovis ANZ RA/QA Manager
MDSAP certification for Australia and the US, delivered at 360MedCare
Class III implant submissions through to Prescribed List inclusion
Four businesses, one site: integrated Lima, 360MedCare and Mathys after an acquisition
NDIS audit, passed
BSI-trained ISO 13485 Lead Auditor
Boston Scientific · Trinity Biotech · Mylan · Johnson & Johnson · 360MedCare · Enovis
ISO 13485 · ISO 9001 · ISO 14971 · MDSAP · EU MDR · 21 CFR Part 820 · GMP · NDIS Practice Standards
Who I work with
Start-ups
Founders building their first device or regulated product. A QMS sized for a small team, coached so your people can run it, and a clear path to certification and approval.
Multinationals
Global manufacturers entering or growing in Australia and New Zealand. Interim RA/QA leadership, local sponsor set-up, integrations, site moves and TGA audits.
Universities and research institutes
Research teams turning discoveries into products. Design controls, risk management and the quality evidence partners, investors and regulators expect.
NDIS providers
Audit preparation from someone who has passed an NDIS audit. See NDIS services
How I work
Listen first. A 20-minute call to understand your product, your market and where the pressure is.
Size the system. I tell you what you need, what you can skip, and what it will cost.
Build it with your team. I write what's needed and coach your people to run it, so the knowledge stays in your business.
Stand beside you at audit. Pre-certification reviews, mock audits and support on the day.
I know the difference between need-to-have and good-to-have.
Book 20 minutes.
Tell me where you are and where you need to get to. If I'm not the right fit, I'll tell you who is.
Dave Tiernan · Noosa Heads, QLD
0420 548 781 · info@bespokeqs.com · LinkedIn