EXPERTISE
STRATEGY
- RA Strategy
- QA Strategy
- Clinical Strategy
- V&V Planning
- Market Strategy
- Publication Strategy
DESIGN
- Device Requirements
- RMF (Risk Management)
- Usability
- Product Validation
- DHF
- VMP, V&V
- SDLC
- Cyber Security
- Information Privacy
MANUFACTURING
- Transfer To Production
- CAPA
- ECO
- DMR, DHR
- IQ, OQ, PQ
- Agreements
- Subcontractors
- Turn Key
QMS QUALITY SYSTEM
- Gap Analysis
- Establishment
- Implementation
- Training
- Audits
- e-QMS
CRO
- Submission File
- Clinical Trial Conduct
- Clinical Trial Management (CIP, ICF, IB; eTMF, SOPs, CSRs)
- Clinical Writing (synopsis, protocol, articles)
- Monitoring
- Site Inspection
- Study Management
- EDC / eCRF
REGULATORY SUBMISSIONS
- Technical Documentation
- FDA (PMA, 510k, Denovo)
- Standard & Guidances
- MDR / IVDR
-
Medical Writing
(PMS, CER, PSUR) - Latam, Asia, Amar
AUDITS
- ISO 13485
- ISO 27001
- MDSAP
- MOCK FDA
- MDR / IVDR
- Clinical Trial Audit
- ISO 14155
SALE PHASE
- PMS
- Labeling, User Manual
- Publications
- Promotional Material
- PRRC
- Economic operator i.e. distributor, Importer
TRUSTED BY
