Turnkey Project Consultation
At Medral Global, we provide comprehensive Turnkey Project Consultation for medical devices and in vitro diagnostics (IVD) under the strict guidelines of the Central Drugs Standard Control Organization (CDSCO). Our mission is to assist manufacturers through every phase of the project lifecycle, ensuring that facilities meet regulatory standards while operating efficiently and maintaining product quality.
Our specialized services cover every aspect of setting up and validating a medical device or IVD manufacturing facility, from facility design to cleanroom validation. This end-to-end consultation ensures that companies can focus on innovation and production, leaving the technical, regulatory, and operational complexities to us.
Our Turnkey Services Include:
- Medical Device / IVD Facility Design
We develop facility layouts that:- Optimize workflow efficiency
- Meet regulatory and Good Manufacturing Practice (GMP) standards
- Accommodate current production needs and future expansion
- Consider equipment placement, process flows, and material handling
- Medical Device / IVD Clean Room Consultation
Our cleanroom design services help:- Construct cleanrooms compliant with international standards like ISO 14644
- Maintain contamination-controlled environments
- Ensure the specific cleanliness classification needed for your operations
- Uphold product safety and quality
- HVAC Design Services
We ensure HVAC systems are:- Tailored to environmental control needs of medical device/IVD production
- Capable of maintaining optimal air quality, temperature, and humidity
- Efficient, safe, and compliant with CDSCO standards
- Integrated seamlessly into your facility infrastructure
- Clean Room Validation Services
We validate cleanroom performance by testing for:- Air filtration efficiency
- Airflow patterns
- Particle count monitoring
- Compliance with required operational standards
- Readiness for regulatory approval and consistent sterile conditions
Why Choose Medral Global’s Turnkey Project Consultation?
- End-to-End Support
From initial concept to full facility commissioning and regulatory compliance. - Risk Mitigation
Minimize risks related to operational inefficiencies or regulatory non-compliance. - Reduced Time to Market
Streamline project execution and speed up the launch of your product. - Regulatory Confidence
Adhere fully to CDSCO and international standards with expert guidance.
At Medral Global, our goal is to make the journey from concept to production as smooth as possible. By offering a comprehensive range of services under CDSCO guidelines, we enable manufacturers to bring their innovative medical devices and IVD products to market with confidence.
With our expertise in:
- Facility design
- Cleanroom consultation
- HVAC design
- Cleanroom validation
…we ensure that your facility meets the highest standards of safety, efficiency, and regulatory compliance.