Services
What We offer
Regulatory Affairs Services
- Regulatory Strategy.
- Device Classification.
- Technical Documentation Compilation / Remediation (MDR).
- Product Support.
- Global Product Registrations.
- PRRC (Person Responsible for Regulatory Compliance).
- UK Responsible Person.
- Remote Services.
Quality Assurance Services
- Full QMS (Quality Management System) Implementation.
- QMS Gap Analysis.
- Audits as Lead Auditors (IRQC / CQI).
- ISO14971 Risk Management.
- Process / Equipment Verification & Validation.
- Post-Market Surveillance.
- Vigilance / Recalls.
- Quality Control.
- Training.
- GxP Support.
Project Management
- IPMA (International Project Management Association) Certified.
- Six Sigma Qualified.
- Full Product Compliance Support.
- Complete QMS Implementation.
- LEAN Process Manufacturing Support.
- Validation Projects.
