Our Services
Core Services
Biocompatibility Assessment
BEP, BER, and Toxicological Risk Assessment to ISO 10993. Our team includes ERT-Certified Toxicologists with experience across a wide range of device types and material categories.
Validation Services
IQ/OQ/PQ, Sterilisation (EtO/ Gamma/ Moist Heat), Process Validation, Equipment and Utility Qualification, Cleanroom Validation, and Computer System Validation (CSV). Full lifecycle support from master planning through to remediation. ISO 13485, GHTF, FDA CFR.
Cleanroom Design & Testing
Design Consultation, Classification Testing to ISO 14644, Environmental Monitoring, Commissioning, and Ongoing Compliance Support.
Regulatory Compliance
Strategic and practical support across ISO 13485, FDA 21 CFR Part 820, EU MDR, IVDR, and MHRA — including regulatory strategy, submissions, technical documentation, and gap analysis.
Quality Management Systems
QMS Design, Implementation, and Certification across ISO 13485, ISO 9001, and ISO 14001 — including CAPA systems, internal audit programmes, and continual improvement.
Additional Services
Auditing & Training
MHRA, FDA, and ISO audit preparation, mock inspections, and training programmes.
Gap Analysis & Audit Support
Pre-audit readiness assessments and support during regulatory inspections.
SOP & Technical Documentation
Development and review of SOPs, work instructions, and technical files.