Shah is an experienced Quality System Consultant with
special emphasis in medical devices. An expert in auditing
and determining the adequacy, effectiveness, and degree of
the company’s compliance to the standards and regulations:
ISO 9001, ISO 13495, Quality System Regulations & c-GMP.
He is an
experienced regulatory consultant in European Medical Device
directives for CE certification of medical devices, FDA
requirements like 510k compliance and c-GMP certification
regulations for manufacture of medical devices including
sterile devices and drug device combination products.
demonstrates their expertise in preparation of Device Master
File, eCTD, for devices from class 1 to class 4 (Ito III or
A to D) and related documentation like Quality Manuals,
Policies, Standard Operating Procedures.
consults in preparation of Drug Master File (DMF) for API
and regulatory submissions.
and his team have done projects on designing of medical
device manufacturing plants and executing commissioning of
medical device manufacturing companies have complied with
QMS as per 13485 & their devices have obtained CE marking
under his guidance.
He has been
adviser for technology transfer on Coronary Stents including
Drug Eluting Stents including execution of international
gathered experience in due diligence of medical device
purpose of consultations and audits, he has travelled widely
all over the world including many European Countries, USA,
China, Taiwan, Middle East etc.
attended and addressed many conferences and exhibitions in
Brussels, Baltimore USA including Medica at Dusseldorf more
He is the
founder of consulting company UNIKAL CONSULTANTS
He has done
his Masters in applied Science from University Department of
Chemical Technology, Bombay University now Institute of
Chemical Technology (an University)
He is a
certified Lead auditor for QMS
on regulatory compliance for like
He has held
various INDUSTRIAL POSITIONS like Chief Consultant at UNIKAL
CONSULTANTS, Partner of URALAB, Mumbai; Technical director
of UNIKAL CHEMICALS PVT. LTD., he was on the board as
independent director of a public limited pharma company and
chief technical adviser at Sahajnand Medical Technologies