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“Thinking ‘Pharma’ To Manage Risks In Medical Device Industry”

The title sounds strange because industry feels medical device is different from pharmaceutical products. Their usage, application, regulatory requirements are all different but at the same time they are all part of health care.

Medical device is at an unique position where it may be used for a few seconds to implanted for a life time of patient. It may have energy to deliver or use various energy sources for diagnosis and treatment. It is a all covering term for equipment used in the treatment of a patient and there is no limit to its scope as far as a device is used for patient care and treatment.

This uniqueness brings in a system of classification based on the risk in use of a device. Here comes accuracy, sensitivity and exactness of pharma product into play. Unless we think of cGMP in its design, production and usage along with GXP like GLP, GCP, GDP the risk and benefit of usage of a device will not remain in balance.

We need to understand this and only if we understand it we can make regulations, we can implement regulations and practise these cGXP while desigining, manufacturing and using medical devices.

Mr. Sanjay Shah
Owner Promoter

Unikal Consultants, Ahmedabad

Mr. Sanjay 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.

His company 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.

His company consults in preparation of Drug Master File (DMF) for API and regulatory submissions.

Mr. Shah and his team have done projects on designing of medical device manufacturing plants and executing commissioning of these plants.

Many 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 project.

Has gathered experience in due diligence of medical device manufacturing plants.

For the purpose of consultations and audits, he has travelled widely all over the world including many European Countries, USA, China, Taiwan, Middle East etc.

He has attended and addressed many conferences and exhibitions in Brussels, Baltimore USA including Medica at Dusseldorf more than once.

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

consulted 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 Ltd. Surat.