Login

ART Level 1 Setup — A Clear, Risk-Free Path to Compliance

Our five-step implementation process turns intent into certified capability.

Our 5-Step Implementation Process

We’ve developed a proven methodology that transforms your vision of establishing an ART Level 1 clinic into a fully operational, certified facility. Each step is designed to minimize risk, maximize efficiency, and ensure regulatory compliance.

1️⃣ Assessment Call

We begin with a comprehensive evaluation of your existing facilities, projected patient caseload, staff capabilities, and specific business goals. This initial discovery phase allows us to understand your unique context and challenges.

Deliverable: Detailed site readiness report with actionable recommendations.

2️⃣ Compliance Checklist & Blueprint

Based on the assessment, we create a customized compliance checklist aligned with the latest ART Act and ICMR requirements. This includes detailed lab layout drawings, equipment specifications, and workflow designs tailored to your space and needs.

Deliverable: Comprehensive project blueprint with regulatory alignment.

3️⃣ Procurement & Vendor Shortlist

We assist with sourcing CE-quality equipment including centrifuges, incubators, laminar flow hoods, microscopes, and validated consumables. Our vendor-neutral approach ensures you get the best value without compromising on quality or compliance.

Deliverable: Vetted equipment list with cost-optimized quotes.

4️⃣ Implementation & Training

Our team provides on-site or remote supervision during installation and commissioning. We conduct hands-on training in sperm washing techniques, IUI lab workflows, and quality control procedures, with competency assessments for your staff.

Deliverable: Operational lab with certified, competent team.

5️⃣ Final Audit & Certification Support

We conduct rigorous mock audits to prepare your team for the regulatory inspection. Our support includes documentation handover, compliance dossier preparation, and liaison assistance with regulatory authorities.

Deliverable: Audit-ready status with certification pathway.

KPIs & Timeline

Typical turnaround: 4–10 weeks depending on scope

Our efficient process ensures your clinic achieves ART Level 1 readiness in the shortest possible time frame, with minimal disruption to your existing operations.

Key Deliverables

  • Detailed site drawings and layout plans
  • Comprehensive equipment list with technical specifications
  • Complete SOP pack tailored to your clinic
  • Staff training certificates and competency records
  • Audit-ready compliance dossier

Frequently Asked Questions

  • How long does a full implementation take?
  • The typical implementation timeline ranges from 4–10 weeks, depending on factors such as retrofit versus new build, procurement lead times, and the complexity of your specific requirements. We provide a detailed project timeline during the assessment phase.
  • Can you work with my chosen equipment vendors?
  • Yes, we can validate and work with your preferred equipment vendors. Our role is to ensure their specifications meet regulatory requirements and integrate seamlessly into your lab workflow. We provide technical evaluation to protect your investment.

Begin Your Clinic Setup Journey

Get a customized setup blueprint tailored to your specific requirements and space constraints.

Get My Custom Setup Blueprint