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Managing Director of
Sahajanand Laser Technology Ltd., Gandhinagar since
2002. SLTL is a special-purpose machine
manufacturing group and is specialized in exclusive
designing, developing, manufacturing, marketing and
servicing sophisticated Laser systems and CNC
machines.
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From 1989 to 2001,
worked as a Managing Partner / owner with
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Sahajanand Laser
Technology, Gandhinagar,
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Sahajanand Laser
Mechanica,
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Sahajanand Electronics
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Worked as a Sr.
Engineer, GNFC, from 1986 to 1988
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Worked with Space
Application Centre, ISRO from 1984 to 1986
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Did business in the name
of Micro Electronics and Control during 1981 to 1984
Innovation :
Developed following machines under his guidance and
research :
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Hallmark 007, Laser
Sawing Machine
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Akshar Pro Hallmark,
Laser System for Hallmarking on Jewllery
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SLT-SS, Laser System for
Solar cell cutting
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Bhramastra - High Power
CO2 system for sheet metal cutting
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Airwin Diagnoses - Laser
Diamond planning and mapping systems
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Q-top: Laser Bruting
system
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Hallmark TSP: Two side
laser bruting and sawing system
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Luster plus: Robotic
diamond planning system
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GIZMO: Laser Cone
bruting system
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Fiber Laser Sheet metal
cutting machine
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Akshar Fiber Pro: Laser
marking system
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Laser Welding system
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Laser Surgical system
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Machines for Industrial
Laser CNC applications
Mr.
Dhiren Mehta - Managing Director - Surgimedik
Healthcare India Pvt. Ltd.,, Mumbai
Career
Summary:
Professional with extensive experience in developing
products and business in the areas of Medical Devices.
Successfully bridges between technology and
commercialisation.
Professional Experience:
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Managing Director: Medi
Surg GmbH, Frankfurt, Germany, Year-2011 till date
Formed company in Germany to market medical devices
worldwide
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CEO: Surgimedik
Healthcare, Surat, India,Year 2007 - till date
Formed company in Special Economic Zone to
manufacture products for urology, gastroenterology,
women's health, nephrology and radiology and export
to various countries.
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President - Allwin
Medical Devices, USA, Year 2005 - till date Formed
company in USA to market medical devices worldwide
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Managing Director :
Surgimedik Healthcare India Pvt Ltd, Mumbai , India,
Year 1998 - till date. Manufactures Medical Devices
for Urology, Gastroenterology, Women's Health,
Nephrology and Radiology.
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CEO: DVM International,
India ,Year 1993-97 Distribution of Medical devices
representing Bard, USA, Baxter Healthcare Inc, USA.
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Product Manager: Bard,
USA , Year 1987-92 Appointing Distributor in Asia
countries and promoting new products.
Dr. Subodh Adhesra -
Former Commissioner, FDCA, Gujarat State
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He has done M.Pharm. in
1976 with Specialization in Pharmaceutics and
Pharmaceutical Technology.
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Ph.D. was awarded by
Gujarat University in 2003
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14 years experience in
manufacturing of pharmaceutical products includes -
Liquid & Dry Powder Parenterals, coated, uncoated,
film coated, sugar coated and sustained release
tablets, B-Lactum and Non-B-Lactum capsules, Soft
Geletin Capsules, Ayurvedic products etc.
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Three years experience
in Research & Development Pharmaceutical
Formulations with multi-national company
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In the capacity of Joint
Commissioner (Food & Drugs), worked for about 7
years
|
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Member of Drugs
Technical Advisory Board.
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Member of Drugs
Consultative Committee.
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Member of D.C.C.Sub-committees.
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Member of Indian
Pharmacopeia' Commission.
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Co-ordinating and
monitoring the works of all the Circle Offices
Mr.
Sanjay Shah - Owner Promoter, Unikal Consultants,
Ahmedabad
Mr.
Sanjay Shah is an experienced Quality System
Consultant, knowledgeable in ISO 9001 & ISO 13485 for
medical devices. He is 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
also an experienced regulatory consultant in CE
certification regulations of medical devices as per
MDD/ 93/42 and c-GMP certification regulations
regarding manufacture of medical devices and active
pharmaceutical ingredients (bulk drugs), formulations
and sterile devices. He has an experienced in US FDA
Device registration process under 510(k).
He
demonstrates expertise in preparation of Device Master
File, CTD, for specific devices from class 1 to class
4 (A to D) and related documentation like Quality
Manuals, Policies, Standard Operating Procedures, Drug
Master File (DMF) for API and regulatory submissions.
Mr.
Sanjay is an adviser too for technology transfer on
Coronary Stents including Drug Eluting Stents to many
companies. Experience in due diligence of medical
device manufacturing plants.
He has
attended / addressed many conferences and exhibitions
like Medica, Dusseldorf.
He
founded consulting company UNIKAL CONSULTANTS.
He has
done Masters in applied Science from University
Department of Chemical Technology, Bombay University
now ICT (an independent university)
Industrial Positions:
-
Unikal Consultants - Chief Consultant
- Uralab Partner
- Unikal Chemicals Pvt. Ltd. Technical Director
Mr.
Deepak Dave - Vice President - Medical Surgical And
Healthcare Industries Trade Association & Ashutosh
Export Inter., Mumbai
Mr.
Deepak Dave is CEO of Ashutosh Export International,
Mumbai, presently carrying on the business in the
Medical Devices and Surgical Equipments including
Disposable Products.
He has
done his graduation from Mumbai University with
specializing in the field of Economics & Marketing.
Post graduation in MBA. He has been in this field of
Medical Devices and Surgical instruments and
Equipments for past 24 Yrs.
He
started the career working with an MNC in Mumbai as
Asst. Purchase Officer and relinquished the job after
9 Yrs of very rich experience in the field of Local
Purchases & Imports. He entered into the field of
Medical Disposable business in the year
1987.
It has
been his privilege to be associated with the first in
bringing new products and concepts for the INDIAN
market and consumers which much necessary for the
growth of Indian market in terms of availability and
prices.
Having
the exposure for more than 15 years of international
market in the medical and surgical products and
devices including the Healthcare sector, he further
developed into selling some of the patient friendly
products for specialized products at affordable prices
in INDIAN market. To keep with the newer products
introduced after innovation by manufacturer of
international brands is also Mr. Deepk’s passion.
He has
been the only person in INDIA to set up 6 Human Milk
Banks in INDIA. His wishful dream is to create a
“White Revolution” by setting up Human Milk Bank in
each and every hospital work for better future
generation to come of this country. |
Dr.
Samuel JK Abraham, II Dept. of Surgery, Yamanashi
Medical University, Japan
Dr.
Samuel is affiliated with the Division of Cardiac
Surgery and also Dept. of Clinical research, Yamanashi
University, Japan and with Nichi-In Centre for
Regenerative Medicine, Chennai, India (www.ncrm.org).
He is a technical advisor to M/s GN
Corporation and M/s Medius Holdings in their medical
devices coding system development and implementation.
Mr.
Hisayuki Furuki - Executive Director - Medius
Solutions Co. Ltd., Japan
Executive director of Medius Solutions Co Ltd, a group
company of Medius Holdings which is a JASDAQ listed,
medical devices, consumables and equipment
distribution company.
He is
the key person behind the development and
implementation of the “MECCUL” medical consumables
coding system in Japan.
Mr.
Kanwal Jit Singh - Proprietor - Surbhi Financial
Technologies, Pune
He is
working as an independent consultant for regulatory
affairs for:
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Medical Devices :CE Mark
Certification, Listing and Registration with US FDA.
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Mechanical and
Electrical Products – CE Mark Certification : ATEX
and Normal Environments
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Sustainability and
Corporate Social Responsibility : Including Carbon
Foot printing and Water Foot printing
He has
worked as Technical Director of two Certification
Bodies that represented 3 Notified Bodies in India and
Hong Kong. He was Promoter Director of the first
Indian owned company authorised to certify Voluntary
Emission Reductions of CO2 as per the Protocols
defined by Chicago Climate Exchange.
He is a
member of the Technical Committee to formulate the
Protocol to certify carbon emission reductions by
hydroelectricity projects. He is the only member from
the developing world and the others are included
officials from World Bank.
His
authored articles in various areas published in India,
US and UK.
Medical
Devices – 3 articles published in Journal of Medical
Device Regulations, published in London.
Dr.
Sanjeev Kumar Gupta - Managing Consultant, Intrust,
Mumbai
Dr.
Sanjeev Kumar Gupta obtained his doctorate
(Biotechnology) at the IIT-Roorkee, Uttranchal, India
and postdoctoral training at MRC Immunochemistry
Laboratory, Department of Biochemistry, Oxford
University, Oxford, UK. His work on C1q molecule
was awarded by American Association of Asthma, Allergy
and Immunology, USA. He has practical and research
experience in the areas of biochemistry, immunology
and protein chemistry. He has published over 200
articles in various continuing medical education
magazines, research papers in peer reviewed journals,
chapters in books and 2 books.
He is
certified for Quality Control, Quality Assurance,
Internal Auditor, Deviation & Change Management, CA,
Risk Management as per the requirements of ISO
13485:2003 (2012), ISO 13485:2003 CMDCAS, ISO
9001:2008 and Drugs & Cosmetics Act. Having worked in
different kind of industries he has gathered expertise
to customize QMS and its implementation as per
requirements of standards. He has developed successful
modules for Post Marketing Surveillance, Vigilance,
Customer complaints and Feedback.
His
career in QA and Regulatory Affair now spans over 18
years in different healthcare industries including
Medical Devices and In Vitro Diagnostic Devices. He
last worked as General Manager-QA/RA at Span
Diagnostics Limited, Surat He has been a faculty to
Capacity Building Program at NIPER, Mohali for Drugs
Control Officers of India during 2006-2008.
Currently he consults for ISO 13485:2003 (2012) based
QMS, strengthening internal audit process, development
of training modules, customization of documents and
records, establishment of real time process
interactions, risk management training and
documentation and change management. |