Product management across all lifecycle stages.
Design Control Documentation to all key ISO standards.
Outsource design vendor management
Rigorous design review for quality outcomes.
Product Safety Test Planning
Global compliance for key standards – IEC 60601, IEC 61010, IEC 62304
Selection and management of external test organisations
Global Manufacturing search and selection.
Production process design and validation.
Transfer from design to manufacture.
Company Director Tom Stamp is highly experienced in medical device development, manufacturing and regulatory approval. Our team of area experts covers hardware, mechanical, software and systems design.
Our document writers are experienced with all key IEC, ISO, FDA, TGA and CE medical device standards.