• +91 9744722260    +91 8848674243
  • services@iqzyme.in

Services

Turnkey Project Consultation-Clean Rooms for Medical Devices Manufacturing

Clean Rooms For Medical Device Manufacturing

IQZYME keeps highest professional standards in providing the following services as part of Turnkey Project Consultation to our Customers.

From Concept To Commissioning Of Clean Room Manufacturing Facilities:

We provide the complete range of services including Architectural, Civil, Structural, Mechanical, Water Treatment, Electrical, ETP, Fire & Safety Systems HVAC, and Validation Services for Class 100, Class 10,000 and Class 1, 00,000 Clean Room facilities as per ISO 13485 and ISO 14644 Clean Room Design Standards

One Stop DPC (Design, Procurement & Construction) Solutions To Customers:

We assist our clients in finalizing the design and procurement of suitable machineries and their validation at different stages.

Technology Sourcing And Consulting For IVD /Medical Devices:

At IQZYME, we assist our customers in sourcing technologies for IVD/MEDICAL DEVICES that are ready for commercialisation. We also provide exclusive consultation services to research groups and academic institutes to achieve maximum compliance of their research product to existing quality standards which will in turn helps in a smooth and successful technology transfer and commercialisation.

CGMP Auditing

We audit the existing and or new Medical Devices / IVD Manufacturing facilities to conform their compliance with the current GMP Standards of local and International Regulatory authorities viz:

  • CDSCO / MDR 2017
  • EU GMP (MDR 2017/745 & IVDR 2017/746)
  • US FDA
  • WHO

Market Analysis & Feasibility Studies For IVD/Medical Devices

IQZYME undertakes feasibility studies of Medical Devices / IVD to customers which comprises of:

  • Market Study
  • Technical Study
  • Financial Study