'Mini-Workshop Series on Regulatory Requirements for Medical Devices' Topic: How to become an ISO 13485 Certified Medical Devices Company?
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Friday | 26 Oct 2018 | Time 1345-1730 Hrs
Venue: Lecture Theatre, Venture Center, 100 NCL Innovation Park, Dr. Homi Bhabha Road, Pashan, Pune, Maharashtra, 411008
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The workshop will focus on the structure, importance, and Quality Management System (QMS) requirements as per the standard
• What is ISO 13485 standard – Terms, Definitions& Background
• QMS requirements – Contents, Documentation, and Control
• Benefits of certification – Credibility, Market Access, Improved Product Quality or Service
• Risk-Based Process Approach – Analysing, Evaluating, Controlling and Monitoring Risk
• Implementation strategy – Know How: Planning, Implementing, Managing
• Interactive exercises – Individual and Group
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For Whom
• Individuals and/ or organizations involved in one or more stages of the life-cycle of a medical device,
• Research (PoC/ Design and development)
• Production, storage, and distribution,
• Installation, Servicing and final decommissioning and disposal
• Suppliers of Raw material and components
• Service providers of sterilization, calibration, distribution, and maintenance
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Maximum 30 seats; First-come-first-serve. Limited seats!!
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Registration Process:
• Step 1: Interested participants need to fill the registration form
• Step 2: Organizers will screen applications for suitability for the program based on information provided. Preference will be given to startups and micro/small enterprises.
• Step 3: Selected participants will be sent email invitations. Participants will need to deposit Rs 500 (online or in person) as a refundable deposit to book/confirm their seats.

Seats and Registration Cost: Courtesy of BRBC, there will be NO registration fees.
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Email address *
Full Name *
Your answer
Mobile Number/ Telephone *
Your answer
Designation *
Your answer
Company/ Organization/ Institute affiliation *
Your answer
Type of compmay *
Device Category *
Required
Class of the Medical Device (As per MDR 2017) *
Is your device notified in India? *
Stage of Device Development *
Do you have ISO 13485 certification/ QMS in place? *
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