ISO 13485: 2016 Awareness on Quality Management System for Medical Devices

Program Title: ISO 13485: 2016 Awareness on Quality Management System for Medical Devices

This training program provides an overview of the ISO 13485: 2016 standard, which specifies requirements for a quality management system (QMS) for medical devices. Participants will gain an understanding of the standard’s structure, key clauses, and regulatory requirements, and learn how it applies to the design, development, production, and maintenance of medical devices.

Why to Attend?

• Understand the core requirements and intent of ISO 13485:2016

• Learn how the standard supports regulatory compliance for medical devices

• Gain clarity on risk-based thinking, documentation, and process controls

• Understand roles and responsibilities within a medical device QMS

• Ideal starting point before implementation, internal audit, or certification

• Enhance organizational readiness for regulatory and certification audits

Who Can Attend?

• Medical Device Manufacturers & Start-ups

• Quality Assurance / Quality Control Professionals

• Regulatory Affairs Personnel

• Production, Process & Design Engineers

• Management Representatives

• Internal Auditors

• Consultants & Students aspiring to work in the medical device sector

• Suppliers & Service Providers to medical device manufacturers

When Should You Attend?

• When planning to implement ISO 13485:2016

• Before applying for manufacturing license or certification

• When upgrading from ISO 9001 to ISO 13485

• Prior to internal audits or regulatory inspections

• When onboarding new employees into QMS or regulatory roles

• When seeking basic awareness before detailed training

Program Highlights

• Simple explanation of clauses and requirements

• Easy to understand the standard requirements

• Practical examples from the medical device industry

• Interactive Q&A session

• Certificate of Participation

Mode: Online / Classroom

Duration: 1 Day

Registration Fee: 1000 INR + 18% GST

UPI ID: scinexisglobal@icici

Certification: Awareness Certificate will be Provided

Register now to strengthen your understanding of ISO 13485:2016 and build a compliant medical device quality system.

For more information:

Contact:

Ms. Phani Madhavi 

Email: registrations@scienxis.org

Ph. No: +91-8790862453