ISO 13485:2016 Medical Devices Quality Management System

Organized by: RIFC, Social Innovations and BFI-BIOME Networks Supported by: Venture Center, Pune and Blockchain for Impact

Workshop (Venture Base Camp) on ISO 13485:2016 Medical Devices Quality Management System

– Introduction & Internal Auditors Training Course –

Course Description: An ineffective audit can mean severe consequences, resulting in process failure, patient dissatisfaction, and regulatory noncompliance. Optimize your auditing skills with the internationally recognized ISO I3485:2016 and boost your internal audit capabilities. Gain confidence in planning and performing an effective audit, as well as reporting and taking corrective action where necessary.

This course is intended for medical device quality professionals wishing to build on their current knowledge of ISO 13485:2016 and evaluate the effectiveness of their QMS. It teaches the principles and practices of effective audits in accordance with ISO 13485:2016 and ISO 19011:2011.

 

Get well versed with ISO 13485: 2016 QMS Requirements and Internal Audit Techniques and Programs to ensure Regulatory Compliance in Medical Devices Business.

How will you benefit?

This course will help you:

  • Maintain compliance with ISO 13485:2016
  • Improve a global benchmark in quality standards
  • Be confident that your organization can rely on competent auditors
  • Motivate colleagues through CPD and ensure rigorous regulatory and internal processes
  • Write factual audit reports and suggest corrective actions

The camp will be conducted by a senior auditor from BSI Training Academy, India & Certificates will be issued by BSI Training Academy, India.

Registration Fees and Process

A) Companies who have availed RIFC Services**

  • For one person: 35,000/-
  • For the second person of the same company: 40,000/-

** Discounts will be on the basis of the RIFC services availed

B) Micro/Small enterprises, startups:Non-profit/R&D/academic orgs;Individuals: 40,000/-

C) Others including medium/ large enterprises: 45,000/-

D) Venture Center’s BFIBIOME Fellows and Kickstarters: 100% waiver

Registration Process:

  • Step 1: Interested participants need to fill in the registration form at the following link.  Register online at: https://tinyurl.com/VBC-3days
  • Step 2: Email invites will be sent post-screening of registration details. 
  • Step 3: Attendance only on confirmation of payment of registration fee*.