Resume for Consultant of ISO 9001-2008, ISO 13485-2003 Technical Consultant for IEC compliance and CE Marking

1. RESUME
Sandip N Kulkarni
Address: A1-101, Ankur Residency, Near Cipla Foundation, Warje, Pune-411058
Phone : 09881946595
E-mail: mail2sandipk@gmail.com/director@globaltechnologycentre.com
Education
MBA (MM)
BE( Mechanical)
Professional
Certified Lead Auditor ISO 9001-2008
Certified Lead Auditor ISO 13485-2003
Certified Lead Auditor CE Marking for Medical devices
Faculty for ISO 13485-2003
Technical
Undergone training on IEC 60601 series ( General, Collateral and Particular standards)
Undergone training on EMI/EMC
Undergone training on ISO 10993 series for Biocompatibility
Undergone training on standards related to clean room maintenance and validation
Undergone training on standards related to sterilization
Underergone training on ISO 17025 and ISO 15189 for Laboratory Management
Work Experience:
5 years working experience in Orthopedic Implant manufacturing including surgical instruments
and Medical Electronic equipments for Orthopedic surgery
2 Years working experience with Urology, Gastroenterology, infertility disposables and related
Medical equipment manufacturing
3 years working experience with material handling equipments manufacturers
7 years experience as
a Lead auditor with different European Notified Bodies and Indian Certification bodies as a
freelancer auditor ( approx 600 man-day auditing experience)
Consultant for ISO 13485- 2003 and CE Marking for Medical Device manufacturers
Faculty for ISO 13485-2003
Technical Director for Laboratories for IEC compliance, Biocompatibility and Aging study
( Accelerated/Real Time)

2. Annexure to Resume
A. Working Experience:
Position
Length of
(Title/Function)
Service Area Company time in
position
IEC compliance Testing , compliance to EC directives for
Astute labs Technical April 2012-
general safety, EMI / EMC, Biocompatibility Testing and
Pvt Ltd, Pune Director till Date
Accelerated aging study/ Efficacy study
Safetek January
IEC compliance Testing , compliance to EC directives for Technical
Laboratory, 2011 – April
general safety, EMI / EMC Director
Pune 2012
IEC compliance, compliance to EC directives for general
safety, EMI / EMC and technical guidance on establishment
of the process and validation of the processes of different
machine manufacturers, different medical device
manufacturers, different pressure equipment manufacturers
and general electrical equipments,
coordination in pre-compliance and full compliance testing.
Consultancy to disposable medical device manufacturers
made up of different polymers like polyurethane,
Global
polypropylene, polyethylene , ABS, PVC by plastic injection June 2009
technology Director
moulding and plastic extrusion. till date
Centre
Consultancy to the manufacturers of different electrical and
electronic medical devices and general purpose machines
with processes including casting, forging, machining with
the help of CNC, VMC, Lathe and milling machine, sheet
metal work, powder coating, electrical assembly and wiring.
Consultancy to heavy fabrication works, water treatment
solutions.
Zenith Quality
Management system certification and product certification Head- Product May 2008 to
Assessors Pvt
and third-party inspection services Certification June 2009
Ltd
BMQR
Certifications
Pvt Ltd,
Panel Auditor/ August 2007
Management system certification and SWISO India
Lead auditor to May 2008
Pvt Ltd
September
product certification of medical device directive, machine Moody ICL
2005 to
directive, low voltage directive, electromagnetic compatibility Certifications CE auditor for
September
directive, pressure equipment directive, personal protective Ltd a product
2006
equipments directive, management system certification of certification
medical devices
Manufacturing, design and development and quality
Nasan Design
assurance of electro medical devices (at it embedded,
Medicals manager&
measuring instruments for different human body parameters June 2005 to
Management
for diagnosis and monitoring), body parameters monitoring September
Representative
equipment s 2005

3. Manufacturing, design and development and quality
assurance of polymer disposable medical devices made up of R&D TECH April 2005 to
plastic moulding and extrusion and manufacture of medical INC In charge of QA June 2005
electronic equipments include sheet metal work, fabrication, dept. and MR
electrical wiring and assembly. Special process: wave
soldering
Manufacturing, design and development and quality S.H.Pitkar
assurance of implants made up of stainless steel machining Orthotools
In charge of QA June 2000 to
on CNC and VMC, stainless steel casting including Pvt. Ltd.
dept. and MR April 2005
investment casting, forging, design and maintenance of tools
Jigs and fixtures
Process
development
Autotech
Process designed and quality assurance of MS and SS engineer 10 September
Industries
fabricated structures, heavy fabrication work, installation (combined 1999 to 10
and commissioning. activity of June 2000
production and
QA dept).
Production 19th
Intelligent
Production of overhead conveyor systems, industrial ovens, Engineer, September
conveyors and
vertical causal systems ( sheet metal fabrication/structural member on 1997 to 10
stackers pvt
fabrication, assembly installation and commissioning) development September
Ltd.
committee 1999
B. Training details:
Dates of Location of Training program details
training turning
programs conducted
25.01.2007 Moody ICL ISO 9001:2000 QMS - Internal / External Auditing Techniques : Lead
Certifications Auditors Course - ISO 9001:2000 Quality Management System
Ltd
21.07.2005 Moody ICL BS 7799 ISMS Information security requirements ( ISO 27001) : BS 7799
Certifications ISMS -CIS Information security Manager ( ISO 27001)
Ltd
7th to 9th ITC Zlin Czech Principles and procedures according to ISO 17021
October 2008 Republic Quality manual, procedures and form of CB No. 3002
Quality manual, procedures and form of CB No 3020
Documentation of QMS in production of Medical Devices
7th to 9th ITC Zlin Czech MDD and AIMD conformity assessment
October 2008 Republic Conformity assessment according to IVD Directive
Documentation of QMS in production of Medical Devices
Recertification of OEM-OBL in Medical Devices
Scope of ITC Notification and Accreditation
Assigning of the New Approach Directives to products
Conditions for using foreign laboratories
Condition for including of external auditors into NB auditors team
Guidance for classification of Medical Devices
Third and Centre for Course on Laboratory Competence as per ISO/IEC 17025: 2005 & Aspects of
fourth of May electronic test Internal Audit
2008 engineering
Pune

4. 21-22 Feb Centre for Training course on Medical Laboratory Competence as per ISO 15189:2003 &
2008 electronic test Aspects of Internal Audit
engineering
Pune
13th and 14th ITC Zlin Czech Get acquainted with results of MSCB-3002 activity and economic framework
may 2009 Republic of cooperation
Quality Manual of MSCB-3002
experience with implementation of ISO 17021 requirements at MSCB activity
results of accreditation process according to ISO 17021
procedure of system certification
competence of auditor and technical expert in branches and management
system
submitting)
list of approved auditors and technical experts
evaluation of auditors and technical experts
audit forms and their implementation and certification proceeding
most frequent faults and mistake in filling the forms
approach to specialized selection for auditor or website section 4 auditors
running on different documents of certification body
strategy of certification body for transition period of standard 9001 2008
implementation
meeting the standards requirements
risk management of medical devices
legal requirements related to environmental management system and
occupational health and safety
26 October to CERMET Italy, EC Mark 93/42/EEC and 2007/47/EC Medical Devices Directives and IS0
5 November 13485 requirements in auditing certification processes
2009
23.05.2008 National Technical running on understanding the requirement of IEC 60601,IEC
electrical and 60204, IEC 60950, IEC 61010, IEC 60335, identification of the requirements
electronic from particular standards
laboratory
(West)
Third and Centre for bio- Energy field training course for energy field imaging assessment and research
fourth of field sciences
January 2009
Sixth of National testing methods of bio compatibility of medical devices as per ISO 10993
February 2009 toxicology
Centre
9 September Quality service Assessment of the management system as per ISO 9001, assessment of
2011 Switzerland management system as per ISO 13485, assessment of the management
system as per occupational health and safety requirements, assessment of
the management system as per ISO 13980 requirements
18 January 3 EC Medical device directive and CE marking approach
2011 international
Slovakia
18th 3 EC Auditor training course as per ISO 17021

5. September international
2009 Slovakia
18 January 3 EC Written examination training course of ISO 9001 2008 and ISO 13485 2003
2011 international and medical device directives
Slovakia
14 September 3 EC Written examination training course of new requirements of ISO 17021 2011
2011 international
Slovakia
12 August MEYER, CE marking and new approach directives, operational procedures and
2010 Turkey documents of conformity assessment of the notified body, CE marking scope
of the notified body
Sixth to 8 National Specifications for testing and monitoring to prove continued compliance
February 2011 electrical and with ISO14644-1, airborne article count Class as per IS014644-1, Air-borne
electronic particle and micro biological Classification According to EU GMP & Optional
laboratory tests as per IS014644-3
(West)
9th to 12th National Training program on process establishment according to IS011135-1:2007
February 2011 electrical and Sterilization of health care products –Ethylene Oxide Part 1 and EN 550
electronic
laboratory
(West)
12 to 15th National Training program on particular requirements for safety of infusion pumps
February 2011 electrical and and controllers, training program on particular requirements for safety of
electronic diagnostic and therapeutic laser equipments, training program on particular
laboratory requirements for safety of ultrasonic medical diagnostic and monitoring
(West) equipments
C. Certificate Copies