MedTech Cleanroom facility is commissioned at the Entrepreneurship Development Center (Venture Center), Pune from the support received under the CSR initiative of Bajaj Auto Limited, Pune, and a grant from the Department of Science and Technology, Govt. of India. The facility complies with ISO 13485 Quality Management System standard requirements and is certified by DQS, India. The intent of this facility is to provide services for manufacturing and packaging of medical devices and diagnostics for the purpose of clinical investigations or tests or evaluation or demonstration or training
QUALITY POLICY
Entrepreneurship Development Center is committed to the highest level of quality in the provision of cleanroom facility services for the manufacturing and packaging of non-active medical devices, active(non-implantable) medical devices, implantable medical devices, in vitro diagnostic medical devices by maintaining a reliable infrastructure and compliance with all applicable regulatory requirements and ensuring the effectiveness of the Quality Management System(QMS), Continuous Improvement, Customer and Employee satisfaction.
TEAM
SENIOR MANAGEMENT
- Dr. Premnath V, Director
- Dr. Manisha Premnath, Chief Operating Officer (COO) & General Manager (GM)
QUALITY ASSURANCE DEPARTMENT (QAD)
- Chetna Dharmavat, Deputy MR, QAD
- Prajakta Chitnis, QAD Associate
QUALITY CONTROL DEPARTMENT (QCD)
- Sujaya Ingale, Head of QCD
- M. Vandana, QCD Associate
ENGINEERING AND MAINTENANCE DEPARTMENT (EMD)
- Sayali Kothmire, Head of EMD
- Anjan Kumar, EMD Associate
HUMAN RESOURCES DEPARTMENT (HRD)
- Aditi Nagarkar, Head of HRD
MedTech Cleanroom Facility
Develop, Manufacture, Pack – Commercially Viable Medical Devices and Diagnostics
Cleanroom Facility services for the manufacturing and packaging of non-active medical devices, active (non-implantable) medical devices, implantable medical devices, in vitro diagnostic medical devices, devices incorporating/utilizing specific substances/ technologies.
Built for Environmentally Controlled Technologies & Processes to Meet Biocompatibility Requirements;
Assembly, Machining, Moulding & 3D Printing, Sealing, Filling, Dry& Liquid Reagent Preparation, Powder Preparation, Granulation and Drying, Weaving, Power Checking and Final Cleaning, Wrapping, Primary& Secondary packaging.
Potential Beneficiary Segments;
Orthopaedics, Surgical Instruments & Technologies, Diagnostic Apparatus, Cardiovascular Devices, Diabetes Devices, Dental Instruments & Technologies, Spinal devices, catheters, Internal fixation devices, neuromodulation devices and urology devices.
Regulatory & IP Support
Prioritized support and access to/ from our in house Regulatory and IP departments.
Regulatory Information &Facilitation Center (RIFC)
and
Manufacturing & Packaging
Perform the processing of the devices including assembly, cleaning, and packing in the environmentally controlled, maintained, monitored and qualified cleanroom facilities.
Packaging System Development