Service 03
Regulatory & Quality
A regulatory strategy set early, and a quality system sized for your stage, so approval is a milestone rather than a surprise.
Regulatory
- Strategy — classification, pathway selection and predicate analysis for TGA (ARTG), FDA (510(k), De Novo) and CE marking under the MDR.
- Standards — applying ISO 14971, IEC 62304, IEC 62366, IEC 60601-1 and ISO 10993 to your device.
- Submissions — technical documentation, essential principles / GSPR checklists, clinical evaluation, and submission management.
- Sterilisation and biocompatibility — planning and coordination of ISO 11135 / ISO 11137 validation and ISO 10993 testing.
Quality
- Establishing or right-sizing a quality management system to ISO 13485.
- Design controls, document control, supplier management and CAPA that a small team can actually run.
- Audit preparation and post-market surveillance set-up.
What you get
- A written regulatory strategy with pathway, standards list and test plan.
- A submission-ready technical file.
- A QMS you own and understand.