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Labs & Facilities

IVD & medical device facility design, setup & compliance

Comprehensive support for the planning, establishment, qualification and regulatory compliance of In Vitro Diagnostic (IVD) and medical device facilities — built to achieve compliance while ensuring operational efficiency, product quality and patient safety.

Plan your facilitySee related work

NABL Accreditation

ISO/IEC 17025 & 15189

ISO 13485 QMS

Quality management

CDSCO & MDR 2017

Regulatory compliance

GMP · GLP · GDP

Good practices

01

Facility Design & Infrastructure Planning

Compliant facility layouts engineered around your product risk and quality requirements.

  • Facility layouts aligned to regulatory and quality requirements
  • Space planning for manufacturing, QC, warehousing, utilities and support functions
  • Workflow design for smooth movement of personnel, materials, samples and waste
  • Identification of critical and non-critical areas by product risk classification
  • Design support for HVAC systems, environmental controls and utility requirements
02

Laboratory Classification & Area Segregation

Clean, controlled and support zones segregated to minimise contamination and mix-up risk.

  • Classification of laboratory and production areas by activity and regulatory expectation
  • Segregation of clean zones, controlled areas, testing labs, storage and support zones
  • Unidirectional workflows to minimise contamination and mix-up risks
  • Personnel and material flow assessment against GMP and quality standards
  • Design recommendations for contamination control, biosafety and environmental monitoring
03

LIMS Implementation

Laboratory Information Management Systems configured for data integrity and traceability.

  • Assessment and selection of suitable LIMS platforms for your requirements
  • Configuration of sample management, testing workflows and result reporting
  • Integration with laboratory instruments and quality management systems
  • Electronic data management, audit trails and data integrity controls
  • Traceability systems for samples, reagents, test results and records
  • Training and support for personnel on LIMS operation and compliance
04

NABL Accreditation Support

ISO/IEC 17025 & ISO 15189 readiness — from gap assessment to pre-assessment audits.

  • Gap assessment against NABL and applicable ISO requirements
  • Quality manuals, SOPs, policies, forms and records
  • Quality Management System (QMS) development and implementation
  • Method validation/verification and measurement uncertainty estimation
  • Equipment qualification, calibration and maintenance programmes
  • Internal auditor training, internal audits and management reviews
  • CAPA management and pre-assessment readiness reviews
05

Regulatory Compliance & Documentation

Technical files and document-control systems built to MDR, CDSCO and ISO expectations.

  • Preparation of technical documentation and quality records
  • Support for Medical Device Rules (MDR), CDSCO and international standards
  • Documentation control systems and record-retention procedures
  • Regulatory gap analysis and compliance roadmaps
  • Preparation for regulatory inspections and audits
06

Validation & Qualification

DQ/IQ/OQ/PQ, process, cleaning and computerised-system validation, end to end.

  • Facility qualification (DQ, IQ, OQ, PQ)
  • Process validation and cleaning validation
  • Computerised system validation (CSV) for software and electronic systems
  • Analytical method validation and verification
  • Environmental monitoring programme establishment and validation
07

Training & Operational Readiness

GMP/GLP/GDP and inspection-readiness training to make your team audit-confident.

  • GMP, GLP, GDP and quality-system training programmes
  • Regulatory compliance awareness sessions
  • Laboratory and manufacturing personnel competency assessments
  • Mock audits and inspection-preparedness training
How we work

From concept to audit-ready

01

Plan

Facility layout & infrastructure planning.

02

Design

Classification, area segregation & LIMS.

03

Qualify

Validation — DQ · IQ · OQ · PQ & CSV.

04

Certify

NABL accreditation & regulatory compliance.

What you receive

Key deliverables

An end-to-end approach that enables IVD and medical device organisations to establish compliant, efficient and audit-ready facilities — meeting NABL, CDSCO, ISO and other applicable regulatory requirements.

Facility Layout & Compliance Review
Laboratory Classification Report
Workflow & Area Segregation Plan
LIMS Implementation Strategy
Quality Manual & SOP Package
Validation Protocols & Reports
Internal Audit Reports
NABL Accreditation Documentation
Regulatory Compliance Assessment Report
Audit & Inspection Readiness Support

Building or upgrading a lab or manufacturing facility?

From layout to LIMS to NABL accreditation, we take your facility from concept to audit-ready. Let's map your compliance roadmap.

Talk to our facility team