Evidence led
healthcare technology.
In clinical environments, confidence depends on evidence, documentation and repeatable processes. Mackwell Health builds its platform around independent testing, recognised quality systems and auditable decontamination workflows.
ISO 13485:2016
certified quality management.
Achieved in 2025. ISO 13485:2016 is the most demanding quality management standard in the world for medical device manufacturers. It requires every process - across manufacturing, supply and post-market surveillance - to meet a documented, auditable standard.
Mackwell Health is part of a UK manufacturing group with over 45 years in safety critical electronics. The engineering culture that earned that heritage is the same culture behind our QMS.
Every Mackwell Health product undergoes 100% individual testing - not batch sampling. Not statistical probability. Every single unit, every single time.
Tested at a leading UK biosafety and infectious disease research facility.
UKHSA Porton Down is a major UK centre for infectious disease, biosafety and public health research. We chose to validate our technology there to generate evidence that meets the highest scientific scrutiny.
Real virus infected air passed through the ProtectivAIR® irradiation chamber and analysed in the UKHSA laboratory
Direct comparison with UV-C light on vs off - providing scientifically rigorous, reproducible, peer-reviewable results
Quantitative testing used the MS2 bacteriophage as a conservative viral surrogate; influenza H1N1 transmission was prevented in qualitative challenge testing. Results available for independent review
BS8628:2022 - a significant step forward
in UV-C biovalidation methodology.
For decades there was no recognised standard specifically for validating UV-C surface disinfection. BS8628:2022 changed that, specifying robust test methodology and setting challenging acceptance criteria against resistant micro-organisms. Mackwell Health products have been independently tested against BS8628:2022, with evidence and test reports available on request.
ProtectivAIR®
UKHSA Porton Down tested. Quantitative inactivation demonstrated using the MS2 viral surrogate, with influenza H1N1 transmission prevented in qualitative challenge testing - designed to be the safest device of its kind. Also independently tested by BSI, with certification in progress - final assessment pending.
illuvi® Clean Light
UKAS-accredited 3rd party laboratory verified. Multi-positional coverage that reduces shadowing and repositioning across the clinical space.
illuvi® HD2 range
Microbox-HD2, Minibox-HD2, Tallbox-HD2 - all BS8628:2022 verified. SARS-CoV-2 inactivation confirmed at BSL-3 biosafety level.
Lower-impact workflows.
Our UV-C platform is designed to support healthcare teams in reducing chemical disinfectant waste streams, single use PPE and avoidable environmental discharge.
IUVA
Member.
Mackwell Health is a member of the International Ultraviolet Association (IUVA), an industry body advancing the responsible development, safety and application of ultraviolet technology.
Request the Evidence Pack
ISO certificates, UKHSA test reports, BS8628:2022 verification data, and clinical evidence summaries - for the infection prevention, decontamination, clinical governance and procurement teams who evaluate and approve new technology.
Request documentation→Full Clinical Dossier
Complete technical and clinical documentation for distributor due diligence - product datasheets, verification reports, regulatory filings, and market approval status by territory.
Request the clinical dossier→