Quality systems sized to your business.
Bespoke Quality Solutions designs, audits and runs quality and regulatory systems for medical device companies, NDIS providers and research organisations. Each system is sized to the team that has to run it, and handed over so the knowledge stays in your business.
Experience on both sides of the audit table.
TGA onsite inspection: prepared, hosted and passed
MDSAP certification: delivered for Australia and the United States
Class III implant: taken from submission through to Prescribed List inclusion
Post-acquisition integration: multiple businesses and quality systems consolidated onto one site
NDIS certification audit: prepared and passed
ISO 13485 Lead Auditor qualified
Standards and frameworks
ISO 13485 · ISO 9001 · ISO 14971 · ISO 10993 · MDSAP · TGA regulatory framework · GMP · NDIS Practice Standards
Engagements are scoped as fixed projects, ongoing retainers or interim quality and regulatory leadership.
Who we 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.
Research and universities
Research teams turning discoveries into products. Design controls, risk management and the quality evidence partners, investors and regulators expect.
NDIS providers
Registration, audit preparation and compliance systems, built from first-hand audit experience. See NDIS services
How we work
Listen first. A 20-minute call to understand your product, your market and where the pressure is.
Size the system. We tell you what you need, what you can skip, and what it will cost.
Build it with your team. We 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.
We know the difference between need-to-have and good-to-have.
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It depends on where you start. A small team with no existing system typically needs 6 to 12 months from gap analysis to certification audit. A gap analysis in the first two weeks gives you a realistic date.
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With a gap analysis against the standard you need, then a QMS sized to your team. Start-ups get the smallest system that passes audit, with room to grow as you scale.
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Yes. We cover QA/RA leadership part-time or for a fixed period, through a recruitment gap, an audit, an acquisition or a product launch.
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Yes. We prepare policies, procedures and evidence against the NDIS Practice Standards, run a mock audit, and support you through the certification or verification audit.
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