From a standing start to global approvals in 6 months. A small Australian start-up with only 3 employees were developing a complex software controlled diagnostic device and required a very rapid regulatory approval in multiple markets in order to be able to supply the device for use in a global clinical trial for a medicine. Brandwood Biomedical provided an in house RA/QA Manager who implemented a quality system appropriate to the scale of operations yet fully compliant to ISO 13485 and 21CFR 820. At the same time we guided the client to develop the necessary Technical Dossier to support product registrations in Australia, Europe and North America. ISO certification and all registrations were completed within 6 months of project start.
When starting from scratch it’s important to understand and be very clear about what’s required and what’s nice to have. All too often inexperienced developers are overwhelmed by the scale of regulatory requirements, resulting in designs and systems which are over-engineered and projects which are late and over-budget.
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