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FDA Medical Device requirements: Everything You Need to Know

Device users, importers, manufacturers and distributors of medical devices should comply with the mandatory requirements of 21 … See more

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URL: https://testlabsuk.com/blog/fda-medical-device-requirements-everything-you-need-to-know/

FDA Validation Requirements for Reusable Medical Devices

WEBA minimum of 2 analytes must be measured for the medical device being tested regardless of standard. Cleaning validation standards. AAMI TIR30 – A …

Category: Medical Go Health

HTM 01-01: Management and decontamination of medical …

WEBThe choice of WD to be purchased is dependent on the load it would be used for. HTM 01-01 Part D provides a ‘Particular specification for washer-disinfectors …

Category: Health Go Health

Medical Device Barcode Verification: Everything You Need to Know

WEBMedical device barcode verification. With medical devices, where precision and accuracy are non-negotiable, companies often rely on laboratories to conduct …

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FDA Medical Device Material Performance Requirements – Guide

WEBFDA Medical Device Material Compatibility requirements. As part of the FDA’s safety evaluation process for medical devices, thorough review and assessment …

Category: Medical Go Health

HTM 01-01: Management and decontamination of surgical …

WEBSyeda is a chemist, holding a bachelor’s degree in Chemistry with Medicinal Chemistry and a research master’s degree in Chemistry. Her thesis titled ‘An …

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Delivering a ‘Net Zero’ National Health Service

WEBCOP27. Last year the UK hosted COP26, the latest in a series of UN summits on climate change designed to help participating governments agree on steps to limit …

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Environmental Sampling Services: Case Study Test Labs

WEBEnvironmental sampling can be used to establish the vector of transmissions within a ward and thereby break the chain of transmission, ultimately helping reduce the …

Category: Health Go Health

Post-Market Surveillance (PMS): Everything You Need to Know

WEBWhat is post-market surveillance? According to the EU 2017/745 Medical Device Regulation (MDR), post-market surveillance (PMS) is defined as all activities …

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Mould and Damp Survey Mould Inspection Test Labs UK

WEBAll samples are brought back to our certified laboratory based in Peterborough for processing so that we can issue the report. Contact Us 020 3813 0969 …

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Dental instrument IFU validation in under 4 weeks – Case study

WEBDental instrument IFU validation. Test Labs was contracted out to test and evaluate the instructions for use (IFU) of a re-processable dental medical device (MD) …

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Good Laboratory Practice Everything You Need to Know

WEBToni has 10 years of experience working in a UKAS accredited laboratory within a variety of roles. Prior to working at Test Labs, Toni worked in an ISO 15189 …

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IPC Cleaning Standards in Healthcare Test Labs

WEBCurrent IPC cleaning standards in healthcare settings. In the UK, the most used cleaning solution in healthcare settings contains a chlorine-based agent. However, …

Category: Health Go Health

Mould and Damp Survey: Everything You Need to Know

WEBA mould survey is a laboratory-based scientific process carried out by skilled technicians to determine the presence of mould and dampness. Mould and damp …

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Medical Device Disinfectant CE Mark Guide Test Labs

WEBAs a result, any liquid, spray, wipe, aerosol, or technology intended to disinfect or sterilise a medical device should apply this rule. Written by Toni Carlton …

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BS EN 14255-1: Measuring Exposure to UV Radiation

WEBEven a low-power source of UV-C radiation can be hazardous if a person is exposed to it for long enough. BS EN 14255-1 provides methods for assessing and …

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What are Volatile Organic Compounds

WEBVolatile Organic Compounds (VOC) are organic chemicals that have a high vapour pressure at room temperature and low water solubility. This high pressure is …

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Total viable count: Everything You Need to Know Test Labs UK

WEBEnvironmental Monitoring. Here at Test labs, Total viable count (TVC) is used for environmental monitoring by identifying the level of contaminants in the air, …

Category: Health Go Health