Services
Our Services
Horizon Phoenix Ltd offers quality improvement services in the healthcare sector, including equipment validation, internal audits, regulatory advice, cleanroom design and CE certification.
Consulting & Contracting
We are superbly positioned to offer consulting and contracting in the following areas:
- CE Marking / Testing / Certification
- Quality Assurance / Validation
- Contract Manufacturing
- Cleanroom Design
Complete List of Services
- Validation - Equipment, Process, Packaging, Sterilization & Computer
- Attending ISO/EN Surveillance Audits
- Attending Customer Audits
- Maintaining quality system documentation
- Revising/Amending Quality System documentation
- Document Control & Issuance
- Performing Internal Quality Audits
- Assisting with FDA - 510(k) Approvals, PMAs
- Assistance with Contract Reviews (regulatory compliance)
- Assistance in acquiring CE marking approval
- Telephone support on regulatory issues
- Ongoing quality training for employees
- Supplier/Vendor evaluation (on-site)
- Adverse Event Reporting (Vigilance/Global)