Services
Optimization and Customization
of Quality Systems
of Quality Systems
- ISO 13485
- MDSAP
- FDA (21 CFR 820)
Proposal of KPis
adapted to the client's needs
adapted to the client's needs
Strategy and advice
from experience
from experience
- Regulatory Affairs
- Regulatory strategy for R&D products/projects
- Quality Assurance
- Technical Product Documentation (Technical File)
- Operating License
- EtO sterilization
- Vertical integration
- Import and distribution
- Process outsourcing
- Warning Letters
- Usability studies
- CE mark according to EU MDR 2017/745
- Supplier evaluation
Support to Subcontractors/Suppliers of
medical device manufacturing companies
medical device manufacturing companies
- Manufacturer’s License
- Subcontractor’s License
- Support AACC Inspections (AEMPS, FDA, ANVISA…)
- Quality System
Legal roles
- Responsible Technician according to Spanish Law RD 192/2023
- Person Responsible for Regulatory Compliance (PRRC) according to EU MDR 2017/745
Audits
- Internal
- To Suppliers or Subcontractors
- Support during AACC Inspections
- Support during ON and customer audits
