At GAMP Group, 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),USFDA or EUMDR.
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 consultation includes:
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.
At GAMP Group, 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.
Adherence to Standards: Medical device and IVD manufacturing facilities must comply with stringent regulations and standards, such as ISO 13485 and FDA guidelines. A well-designed facility ensures compliance with these requirements from the outset.
Quality Assurance: Proper facility design minimizes the risk of contamination, ensures product quality, and facilitates compliance with Good Manufacturing Practices (GMP).
Optimized Workflow: Efficient facility design streamlines production processes, reduces bottlenecks, and enhances productivity, leading to cost savings and increased output.
Flexibility and Scalability: Facilities designed with future growth in mind allow for easy adaptation to changing production needs and market demands.
Employee Safety: Thoughtful design prioritizes the safety of personnel, reducing the risk of accidents and ensuring a safe working environment.
Risk Mitigation: Identifying and addressing potential risks in the design phase helps prevent costly issues and ensures uninterrupted operations.
Ensuring a sterile and controlled environment is critical for the manufacturing of medical devices and in vitro diagnostics (IVDs). At GAMP Group we offer specialized clean room consultation services to help you establish and maintain clean rooms that meet the highest standards of cleanliness and compliance. Our expert team is dedicated to guiding you through every step of the process, from initial design and construction to ongoing maintenance and validation.
Efficient and compliant HVAC systems are crucial for the manufacturing of medical devices and in vitro diagnostics (IVDs), ensuring controlled environments that meet strict regulatory standards. At GAMP Group, we offer specialized HVAC design services tailored to the unique needs of medical device and IVD manufacturers. Our expert team is dedicated to providing comprehensive support, from initial design and installation to ongoing maintenance and validation.
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303-304, Sahyog Elina, VIP Main Road |
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510-11 , Wind -A, 73 East Avene, |
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204, Navratna Corporate Park, |
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+91 9879594538 |
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