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Sandip N kulkarni: ISO, CE Mark, FDA registration, MDSAP

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Technical Consultant for Training, Internal Audit, supplier Audit, Freelance auditor, consultancy, guidance, support, for CE Mark, ISO 13485 and Regulatory Registrations. Please watch the following videos for my credentials and view my resume below: Video resume: https://youtu.be/7AWnHbjYGc8 My Credentials summary: https://youtu.be/F9NufZLU_UM My Resume and certificates: https://www.slideshare.net/mail2sandipk/resume-and-certificates-sandip-kulkarni-2017 Short CV: https://www.slideshare.net/mail2sandipk/short-cv-88058034

Services

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Internal audit / Gap analysis for ISO 26262: Road vehicles -Functional safety
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Training, Workshop and Handholding for ISO 15223-1
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Training, Workshop and Handholding for EN ISO 14971
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Training, Workshop and Handholding for EN 60601-1
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Training, Workshop and Handholding for EN 62304
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Training, Workshop and Handholding for EN 62366
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Training, Workshop and Handholding for CMMI® for Development, Version 1.3
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Training, Workshop and Handholding for ISO 13485: Clause 7.3: Design evidence file
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Training, Workshop and Handholding for Annexure I of MDD 93/42/EEC
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Training, Workshop and Handholding for EN 60601-1-2
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Latest Updates

We are a Group of consultants offer complete support for 94/9/EC, (94/9/EC: Equipment for explosive atmospheres (ATEX)) for Equipments used in explosive atmospheres. We have a wide variety of consulti...
We are a Group of consultants offer complete support for (EC) 1907/2006, ((EC) 1907/2006: Chemical substances (REACH)) for Chemicals. We have a wide variety of consulting and auditing capabilities tha...
ISO 13485: Quality Management ISO 13485: Quality Management
ISO 13485: Quality Management System for Medical Device Industries: *ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes is an International Organization for ...
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