Innovative Solutions for your unique enterprise

Headquartered in Sydney Australia, Bespoke Quality Solutions is a network of highly qualified quality assurance, regulatory affairs, market access and project management professionals who collaborate with small to medium enterprises delivering cost effective audit, certification and regulatory solutions.

Our organisation specialises in the medical device sector, with 15+ years experience in start ups and large multinationals. We understand the challenges for QA teams to complete internal, supplier, and certification audits on tight budgets, and so offer cost effective services to execute these on your behalf.

We aim to facilitate growing organisations taking the first steps on their certification pathway, and provide insight into eQMS software that is the right fit for the stage you are at, if at all required. We ensure our bespoke quality solutions are designed, implemented, certified and maintained to service your unique enterprise requirements. We have a direct approach that will ensure your organisation is equipped for your market specific requirements.

Do we need a QMS? What certification agency should we use? What are the benefits of a QMS? How do we gain regulatory approval for our device? What standards should we be using to validate our processes against? - We can answer these and more to ensure your organisation is in the best position at any stage of your journey.