A TECHNO-ECONOMIC NEWS MAGAZINE FOR MEDICAL PLASTICS AND PHARMACEUTICAL INDUSTRY
Our 21st Year of Publication
Page  11 of 12

Cover Story

Invited Speakers & Panel Experts : Profile

  • 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.

  • From 1989 to 2001, worked as a Managing Partner / owner with

  • Sahajanand Laser Technology, Gandhinagar,

  • Sahajanand Laser Mechanica,

  • Sahajanand Electronics

  • Worked as a Sr. Engineer, GNFC, from 1986 to 1988

  • Worked with Space Application Centre, ISRO from 1984 to 1986

  • Did business in the name of Micro Electronics and Control during 1981 to 1984

Innovation :

Developed following machines under his guidance and research :

  • Hallmark 007, Laser Sawing Machine

  • Akshar Pro Hallmark, Laser System for Hallmarking on Jewllery

  • SLT-SS, Laser System for Solar cell cutting

  • Bhramastra - High Power CO2 system for sheet metal cutting

  • Airwin Diagnoses - Laser Diamond planning and mapping systems

  • Q-top: Laser Bruting system

  • Hallmark TSP: Two side laser bruting and sawing system

  • Luster plus: Robotic diamond planning system

  • GIZMO: Laser Cone bruting system

  • Fiber Laser Sheet metal cutting machine

  • Akshar Fiber Pro: Laser marking system

  • Laser Welding system

  • Laser Surgical system

  • 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:

  1. Managing Director: Medi Surg GmbH, Frankfurt, Germany, Year-2011 till date Formed company in Germany to market medical devices worldwide

  2. 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.

  3. President - Allwin Medical Devices, USA, Year 2005 - till date Formed company in USA to market medical devices worldwide

  4. 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.

  5. CEO: DVM International, India ,Year 1993-97 Distribution of Medical devices representing Bard, USA, Baxter Healthcare Inc, USA.

  6. Product Manager: Bard, USA , Year 1987-92 Appointing Distributor in Asia countries and promoting new products.


Dr. Subodh Adhesra - Former Commissioner, FDCA, Gujarat State

  • He has done M.Pharm. in 1976 with Specialization in Pharmaceutics and Pharmaceutical Technology.

  • Ph.D. was awarded by Gujarat University in 2003

  • 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.

  • Three years experience in Research & Development Pharmaceutical Formulations with multi-national company

  • In the capacity of Joint Commissioner (Food & Drugs), worked for about 7 years

  • Member of Drugs Technical Advisory Board.

  • Member of Drugs Consultative Committee.

  • Member of D.C.C.Sub-committees.

  • Member of Indian Pharmacopeia' Commission.

  • 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:

  • Medical Devices :CE Mark Certification, Listing and Registration with US FDA.

  • Mechanical and Electrical Products – CE Mark Certification : ATEX and Normal Environments

  • 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.

Page  1  :  2  :  3  :  4  :  5  :  6  :  7  :  8  :  9  :  10  :  11  :  12

Back | Back to Top | Previous | Next