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



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.




  1. Dr. Premnath V, Director
  2. Dr. Manisha Premnath, Chief Operating Officer (COO) & General Manager (GM)


  1. Chetna Dharmavat, Deputy MR, QAD
  2. Prajakta Chitnis, QAD Associate


  1. Sujaya Ingale, Head of QCD
  2. M. Vandana, QCD Associate


  1. Sayali Kothmire, Head of EMD
  2. Anjan Kumar, EMD Associate


  1.  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)


Intellectual Property Facilitation Center (IPFACE).

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

Design, build and develop a regulaory compliant, affordable, durable and attractive packaging system with the help of our experts in packaging materials, equipment, systems and regulations.
We follow packaging integrity regulations and tests according to ISO, ASTM, GB / T, etc. standards.