Medical Device Turnkey Plant Setup

Medical Device Turnkey Plant Setup
Comprehensive Engineering & Consulting Solutions from Concept to Commissioning
At Isha’s GMP Consultancy, we provide end-to-end solutions for setting up medical device manufacturing plants, ensuring regulatory compliance and operational efficiency. Our multidisciplinary team of architects, biomedical engineers, MEP specialists, and regulatory experts delivers fully compliant, cost-efficient, and energy-optimized medical device facilities.
We specialize in designing state-of-the-art cleanrooms, HVAC systems, and production environments that meet international standards, ensuring your facility complies with USFDA, EMEA, CE, CDSCO, and ANVISA regulations.
- Concept-to-Commissioning Engineering Solutions
- Regulatory-Compliant Facility Design
- Medical Device Cleanroom Design & HVAC Solutions
- Manufacturing Process Optimization & Validation
Engineering & Design Services
- Conceptual & Feasibility Studies
- Site Master Planning & Architectural Design
- Civil & Structural Engineering
- Process and People Flow Optimization
- Basic & Detailed Engineering
Medical Device Cleanroom & HVAC Solutions
- Certified Cleanroom Design (ISO 14644 Compliance)
- HVAC System Design for Controlled Environments
- Sterilization System Design & Validation
- Airborne Contaminant Control for Production & Packaging
Compliance, Qualification & Validation
- Regulatory Compliance with USFDA, EMEA, CE, CDSCO & ANVISA
- Plant Design Documentation for CE & USFDA Certifications
- Qualification & Validation (IQ, OQ, PQ)
- Site Management & Project Execution
Industry-Specific Expertise
- Neurology
- Orthopedic
- Cardiovascular
- Laparoscopy
- Radiology
- Software (SAMD)
- Anesthesiology
- Combination Products (Drug + Device)
- Endoscopy
- In Vitro Diagnostics (IVD)
- Critical Care
- Urology
Why Choose Isha’s GMP Consultancy?
- Expertise in Global Regulatory Compliance
- Cost-Effective, Energy-Efficient Facility Design
- End-to-End Support from Concept to Commissioning
- Proven Track Record in Successful Facility Setup
Get in touch with us today to set up your world-class medical device manufacturing facility!
Medical Device
- Regulatory Consulting for Medical Devices
- Quality Management Consulting
- Global Product Registration
- Market Entry & Market Research Analysis
- Business Transformation & Growth Advisory
- Export Promotion
- Medical Devices Training Courses
- ISO 13485:2016 Certification
- Medical Device Registration
- Indian Authorized Agent for Medical Devices