Traceability QA & RA Services offers assistance to medical device manufacturers and their suppliers or subcontractors concerning:
– Quality Management System development and implementation,
– Regulatory submissions in Europe, USA, Canada, Australia,
– Device registrations in LATAM and Asian countries,
– R&D and Engineering management from a regulatory view.
Keywords are:
ISO 13485 | 20CRF820 | CMDR | CE marking | 510(k) market clearance | Health Canada Licencing | TGA listing | SS&D registration | CNSC licencing | cooperation
Company’s Keywords:
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