Unikal Consultants Specialized in Consulting and Implementation of Quality Management System

The Company specializes in Consulting and Implementation of:

Quality management System as per ISO 9001, ISO 13485 and CE requirements as per European Council MDD/93/42 & Audits for Projects of Manufacture of Sterile Medical Devices

Documentation & Training for various c-GMP systems including US-FDA, MCA, TGA requirements. ISO 9000 & QUALITY MANAGEMENT SYSTEM, CE CERTIFICATION, US FDA 510k, AUDIT, DOCUMENTATION AND GMP.

Collaborators for EC Services are in Brussels, EU.

Clients include Industries Manufacturing Products like:

Sterile Single use Medical Devices, Infusion sets, Catheters & Tubes, Syringes, Intra Ocular Lenses, IUD, Coronary Stents etc. Engineering Items, Telecommunications, Electronics.

Unikal Consultants is managed by Mr. Sanjay Y. Shah in the capacity of Chief Consultant. His experience in the professional field starts from 1975.

Mr. Sanjay Y. Shah is in the capacity of Chief Consultant of Unikal Consultant. His experience in the professional field starts from 1975. He specializes in Consulting and Implementation of Quality management System as per ISO 9001, ISO 13485 and CE requirements as per European Council MDD/93/42 & Audits for Projects of Manufacture of Sterile Medical Devices ;Documentation & Training for various c-GMP systems including US-FDA, MCA, TGA requirements, ISO 9000 & QUALITY MANAGEMENT SYSTEM, CE CERTIFICATION, US FDA 510k, AUDIT, DOCUMENTATION AND GMP.

Sanjay. Y. Shah

Unikal Consultant