Quality Assurance

Quality Systems evaluations & gap-analysis

Software Validation

Unique Device Identification (UDI) – for CE & FDA

Developing and implementing QMS plans & strategies:

• ISO 13485 compliance & certification

• RISK Based APPROACH

• CLOSED-LOOP TRACEABILITY(CLT)

• CAPA System Management

• Change Control Management

• MRB handling

• Complains handling

• MDSAP Audits compliance (for USFDA, Canada, Japan, Australia, Brazil)