Decontamination and Medical Device testing requirements

Specialist support backed by 18 years in decontamination and 4 years in a testing laboratory environment, both responsible for Quality and Regulatory compliance;

I offer expert consultancy and operational support across the full lifecycle of reusable medical devices, combining deep hands‑on experience in decontamination—including endoscopy reprocessing BS EN ISO 13485 certification and accredited laboratory testing knowledge from an ISO 17025 medical device testing environment.

Whether you are a healthcare provider, device manufacturer, sterile services department (SSD), endoscopy unit, or a service provider, I can help you achieve compliance, safety, efficiency, and regulatory readiness.

1. Decontamination Consultancy Services

Drawing on 18 years of experience and knowledge of decontamination facility requirements and workflows

I offer:

Facility Design, Audit & Compliance Support

Decontamination facility design reviews (dirty → clean → sterile workflow, zoning, unidirectional flow)
Endoscopy reprocessing workflow optimisation (manual clean, AER processing, sterilising / vacuum packing storage)
Review of equipment (washers, AERs, sterilizers, RO plants, environmental controls) to align with standards
Compliance assessments against:
- HTM 01‑01 / HTM 01‑06

Operational Excellence & Quality

Review of SOPs, staff competency programs, and training systems
Root cause investigations for decontamination‑related nonconformities
Internal audits for sterile services/endoscopy reprocessing units
Workflow redesign to reduce cross‑contamination risk and processing delays

Technical File & Documentation Support

URS creation or review for new facilities or equipment procurement
Decontamination risk assessments and validation plans
Support for achieving regulatory compliance for OEMs using external reprocessors

2. Medical Device Testing Support (ISO 17025 Background)

Leveraging four years working within an ISO 17025‑accredited medical device testing facility, I provide:

Testing Strategy & Gap Analysis

Determination of required testing for new or modified devices
Review of manufacturer technical documentation and validation evidence
Risk‑based justification for test selection aligned with device classification

Test Method Development & Support

Support in establishing, reviewing, or validating test methods
Guidance on selecting accredited labs and interpreting ISO 17025 test reports
Assistance with:
- Cleaning efficacy testing
- Residual protein testing
- Bioburden and sterility validation
- Material compatibility studies
- Simulated‑use testing

Technical File / Regulatory Readiness

Integration of testing evidence into:
- Technical files (MDR Annex II/III)
- IFU cleaning/sterilization instructions verification (per ISO 17664)
- Risk management files (ISO 14971)
Support for responses to Notified Body questions.