Turnkey Project Consultation
At IQzyme Medtech, 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 Medical Device / IVD Facility Design service focuses on developing a facility layout that optimizes workflow efficiency while meeting regulatory and Good Manufacturing Practice (GMP) standards. We help manufacturers plan and design facilities that can accommodate their current production needs while allowing flexibility for future expansions. The layout considers critical aspects such as equipment placement, process flows, and material handling to ensure smooth operations and regulatory compliance.
As part of our turnkey solution, we offer Medical Device / IVD Clean Room Consultation to assist manufacturers in designing and constructing cleanrooms that meet international cleanliness standards, such as ISO 14644. Cleanrooms are essential for maintaining the sterile environment required for the production of medical devices and IVDs. Our cleanroom consultation service helps manufacturers create contamination-controlled environments that meet the specific classification needed for their operations, ensuring product safety and quality.
Additionally, our HVAC Design services ensure that your facility’s heating, ventilation, and air conditioning system is optimized for the unique environmental control requirements of medical device and IVD production. Proper HVAC design is crucial for maintaining consistent air quality, temperature, and humidity levels, all of which directly impact product quality and regulatory compliance. We ensure that your HVAC system is designed with efficiency, safety, and regulatory adherence in mind, integrating it seamlessly into your facility.
Validation of cleanroom environments is a critical step in ensuring that the facility is ready for production. Our Clean Room Validation services test the cleanroom for compliance with the required operational standards, such as air filtration efficiency, airflow patterns, and particle count monitoring. This service guarantees that the cleanroom is functioning within the parameters necessary for regulatory approval and is capable of maintaining the required sterile conditions consistently.
Our turnkey project consultation provides companies with a holistic approach to setting up their medical device or IVD manufacturing facilities. By guiding manufacturers through every stage, from initial design to final validation, we help streamline the process of regulatory compliance and facility commissioning. This not only reduces the time and resources needed for project completion but also minimizes risks associated with regulatory lapses or operational inefficiencies.
At IQzyme Medtech, 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, and validation, we ensure that your facility meets the highest standards of safety, efficiency, and compliance.