Medical Device & Laboratory SolutionsRegulated Manufacturing

Precision Analytical Systems & Regulatory Support for Medical Devices

Delivering application-led analytical technology, qualification, and complete lifecycle support for medical device development and regulated manufacturing teams across Ireland and the UK.

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AuditReadiness Focus
AccreditationSupport Available
UK & IELaboratory Coverage
Medical device analytical laboratory instrumentation and testing equipment
Validation Ready

Compliance First

Certified Qualification & Lifecycle Management

Regulatory Compliance

Full lifecycle qualification support

Device Development

Application-focused analytical testing & PAT integration

Analytical Testing

Precision instrumentation for regulated manufacturing

Regulated Technology

Medical Device Applications & Compliance

Analytical technology, qualification services, and lifecycle support engineered for regulated medical device manufacturing and testing laboratories across Ireland and the UK.

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Physical & Analytical
Device Testing & Characterisation
Comprehensive qualification protocols, physical strength profiling, dissolution analysis, and particle sizing for precision medical components.

Biocompatibility screening, mechanical stress analysis, particulate contamination checks.

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QA / QC Assurance
Quality Assurance & Validation
Method development, batch uniformity verifications, and qualification frameworks that guarantee zero-defect release cycles.

Full IQ/OQ/PQ execution, audit-ready data integrity, calibrated reference standards.

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Regulatory Support
Regulatory Compliance
Supporting regulatory compliance needs, data integrity, and qualification frameworks across Irish and UK manufacturing environments.

Electronic signature tracking, validated software lifecycle, regulatory audit packages.

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Cleanroom & In-Line
Manufacturing Line Support
Real-time process analytical technologies (PAT) and in-line instrumentation to monitor production consistency without throughput delays.

Non-destructive inline sensors, cleanroom-ready housings, automated batch tracking.

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Next-Gen Devices
Innovation & R&D Development
Analytical feasibility studies and advanced spectroscopy testing to assist R&D teams bringing novel medical devices to market faster.

Rapid spectroscopic mapping, formulation testing, custom protocol engineering.

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Qualified Instrumentation & Validation Support

All systems supplied come with full documentation packages and compliance advisory.

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Medical Device Analytical Solutions

Analytical Technologies for Medical Device Verification

From drug-eluting stent uniformity to cleanroom particle validation, Antech Solutions delivers application-led analytical instrumentation, regulatory protocols, and full qualification support across Ireland and the UK.

In-line process analytical instrumentation for medical device quality assurance
In-Line PAT
Non-Destructive Core & Coating Verification
Continuous spectroscopic and optical monitoring designed for drug-device combinations, stents, and delivery systems without sample disruption.
Compliance Standard:Compliant data capture
Key Capabilities
  • Immediate detection of formulation variance during extrusion
  • Real-time blend and active content uniformity tracking
  • Seamless integration with cleanroom SCADA architectures
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Precision liquid and airborne particle monitoring benchtop system
Sterility & QC
Sub-Visible Particulate & Packaging Integrity
Automated optical and liquid particle counting systems tailored for sterile barrier verification, syringe barrels, and catheter lumens.
Compliance Standard:USP <788> / USP <789> / ISO 21501 standard testing
Key Capabilities
  • High-throughput sub-micron particulate identification
  • Automated USP compliance reporting with audit trails
  • Rapid container closure integrity (CCIT) screening
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Micro-spectroscopy system analyzing active pharmaceutical coatings on medical implants
Surface Analysis
Surface Layer & Drug-Elution Profiling
Micro-spectroscopic mapping instruments designed to evaluate coating thickness, adhesion consistency, and API release dynamics on implant surfaces.
Compliance Standard:Sub-micron spatial resolution with rapid area rastering
Key Capabilities
  • Chemical uniformity mapping across curved geometries
  • Non-destructive thickness and polymer distribution analysis
  • Validated methods for regulated medical device submissions
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Field engineers carrying out analytical instrument qualification in a medical laboratory
Qualification
Lifecycle Equipment Qualification & IQ/OQ/PQ
Dedicated validation protocols, certified reference standards, and re-qualification services provided across Ireland and the UK.
Compliance Standard:GAMP 5 categorized documentation and on-site engineering
Key Capabilities
  • Pre-execution protocols and full execution documentation
  • Traceable calibration standards aligned with global pharmacopeias
  • Fast-response local maintenance and software compliance reviews
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Regulatory Assurance
Regulatory Data Capture Alignment
Alignment with regulatory data capture protocols
Local Engineering
IE & UK
Direct field service and qualification engineers on demand
Testing Accuracy
Sub-Micron
High-resolution characterization for critical tolerances

Require specific validation protocols or instrument demonstrations?

Speak with Antech Solutions technical specialists for laboratory application support.

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Medical Device Solutions

Specialised services for medical device manufacturers and regulated labs

Antech Solutions supports engineers, quality teams, and laboratory leaders with certified analytical technology, qualification expertise, and life-cycle assurance.

ISO 13485 / FDA
Regulatory & Quality Consulting
Strategic guidance to navigate EU MDR, FDA 21 CFR Part 820, and international medical device qualification requirements.

Key Capabilities

  • Design history file (DHF) auditing
  • Risk management (ISO 14971)
  • Technical documentation review
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Laboratory Services
Analytical Testing Support
Full spectrum verification testing for medical devices, extractables and leachables, drug-device combos, and material integrity.

Key Capabilities

  • Physical & chemical characterisation
  • Sterility & bioburden verification
  • Failure analysis & root cause testing
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Regulated Systems
Compliance & Validation (DQ/IQ/OQ/PQ)
Complete equipment and software validation documentation support for life science operations.

Key Capabilities

  • Validation master plan creation
  • Data integrity risk assessments
  • Periodic re-qualification schedules
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Workforce Upskilling
Technical Training & Workshops
Customised on-site and remote training modules for quality managers, test engineers, and cleanroom operating personnel.

Key Capabilities

  • Good Laboratory Practice (GLP) courses
  • Analytical instrument user mastery
  • Audit readiness simulations
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In-line Monitoring
Process Analytical Technology (PAT)
Implementation of real-time analytical tools for continuous manufacturing monitoring and critical process parameter control.

Key Capabilities

  • Spectroscopic probe integration
  • Real-time release testing strategy
  • Yield and batch cycle reduction
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Preventive Care
Instrument Lifecycle & Maintenance
End-to-end preventative maintenance, rapid breakdown response, and accredited calibrations across Ireland and the UK.

Key Capabilities

  • Certified reference standard calibration
  • Guaranteed emergency response SLAs
  • OEM spare parts management
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Need customized qualification or validation protocols?

Our application specialists can design tailored protocols aligned with your laboratory quality plan.

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Analytical Instrumentation & Lifecycle Support

Ready to optimize your laboratory workflow?

Get application-led analytical technology, qualification, and ongoing lifecycle support tailored specifically to regulated laboratories and manufacturing teams.

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Ireland and UK Coverage

Dedicated regional application and service support teams.

Regulated Compliance

Full qualification documentation for GLP, GMP, and ISO labs.

Application-Led Guidance

Direct access to instrumentation specialists before ordering.