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Contract development and manufacturing of Point-of-Care Diagnostics, Biosensors, and microfluidic test cartridges

FL

FlexMedical Solutions Limited

Livingston (GB) · St-Sulpice (CH)New on Amplifa

2014Founded (Companies House, 23.12.2014)
11–50Employees
ISO 13485Accreditation

About FlexMedical Solutions

FlexMedical Solutions is a specialized contract company for design, development, and manufacturing focusing on In-Vitro Diagnostics (IVD). The company supports customers from the concept phase to the commercialization of Point-of-Care Diagnostics and Wearables. The portfolio includes the design of biosensors and microfluidic test cartridges, product and process development, assay development (Immunoassays, Electrochemistry, Fluorescence, Chemiluminescence), surface functionalization, and reagent formulation, along with regulatory support according to ISO 13485. In its own manufacturing facility in Livingston, Central Scotland, test strips and cartridges are produced using, among other methods, high-precision screen printing systems and ablation lasers for electrode production from gold and carbon, as well as reagent dispensing systems and pick-and-place machines for complete biosensor production. The product range includes test cartridges and wearable sensors for the detection and monitoring of cardiovascular diseases, cancer, and other medical conditions. The facility is located about 20 minutes from Edinburgh Airport and serves Scotland, the United Kingdom, and beyond.

Site
EH54 6GQ Livingston, West Lothian (GB)
Processes
Screen printing for electrode manufacturing, Ablation Laser (Laser Cutting and Ablation) for electrode manufacturing, Reagent dispensing, Pick and place for biosensor production, Design of biosensors and microfluidic test cartridges, Manufacturing of test strips and Cartridges (Point-of-Care-IVD), Surface Functionalization, Reagent formulation and Assay development
Materials
Gold, Carbon
Certificates
ISO 13485
Employees
11–50 (FlexMedical
Industries
In-Vitro Diagnostics (IVD), Point-of-Care Diagnostics, Medical Technology/Wearables, Biosensing, Life Sciences, Dentistry (FlexMedical SA)
  1. 01

    Design of biosensors and microfluidic test cartridges

  2. 02

    Product and process development

  3. 03

    Assay development and reagent formulation

  4. 04

    Electrode manufacturing (Screen printing, Laser ablation)

  5. 05

    Reagent dispensing and Pick-and-Place

  6. 06

    Validation and regulatory support

Materials & Processes

Au

Gold

Material for screen printing electrodes in biosensor applications.

C

Carbon

Material for flexible medical electrodes and screen printing electrodes.

Sites

Livingston

GB

Headquarters & Manufacturing

Lot size
Prototype to mass production
Materials
Gold, Carbon
  • Screen printing system (High precision)
  • Ablation laser
  • Reagent dispensing system
  • Pick-and-Place system

St-Sulpice

CH

FlexMedical SA Site – Dental Technology Distribution (Woodpecker)

Industries

In-Vitro Diagnostics (IVD)Point-of-Care DiagnosticsMedical Technology/WearablesBiosensingLife SciencesDentistry (FlexMedical SA)FlexMedical Solutions: In-Vitro Diagnostics (IVD), Point-of-Care Diagnostics,FlexMedical SA: Dentistry/Dental Practices

Processes & technical limits

ProcessesToleranceMax. partWeightLot sizeMaterials
Screen printing for electrode manufacturingSurface––––Gold, Carbon
Ablation Laser (Laser Cutting and Ablation) for electrode manufacturingMachining––––Gold, Carbon
Reagent dispensingAssembly–––––
Pick and place for biosensor productionAssembly–––––
Design of biosensors and microfluidic test cartridgesEngineering–––––
Manufacturing of test strips and Cartridges (Point-of-Care-IVD)Assembly–––Mass production–
Surface FunctionalizationSurface–––––
Reagent formulation and Assay developmentEngineering–––––

4 Anlagen & Maschinen

MachineManufacturer / modelQuantityWorking areaYear builtSite
Screen-Printing System (High precision)––––Livingston, West Lothian, UK
Ablation laser––––Livingston, West Lothian, UK
Reagent dispensing system––––Livingston, West Lothian, UK
Pick-and-Place system––––Livingston, West Lothian, UK

Additional services

FlexMedical Solutions: Design of biosensors and microfluidic test cartridgesProduct and process development (POC Diagnostics, Wearables)Contract manufacturing: Screen printing electrodes, Laser ablation, Reagent dispensing,Assay development (Immunoassays, Electrochemistry, Fluorescence, Chemiluminescence)Surface functionalization, Reagent formulationRegulatory and QA support (ISO 13485)FlexMedical SA: Exclusive distribution Woodpecker (CH), Demo/test units for dental practices (2

Quality

FlexMedical Solutions is accredited to ISO 13485; all design, development, and manufacturing activities are carried out according to these standards. The company also supports customers with regulatory and quality assurance requirements.

EvidenceLivingston
ISO 13485

History

  1. 2014

    Registration of FlexMedical Solutions Limited on December 23, 2014, in Scotland (Companies House); LinkedIn lists 2015 as the founding year.

  2. 2016

    First trade show participation at MEDICA in Düsseldorf.

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