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Implementation of ISO 13485:2016 Standard (19 to 20 October 2017)

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Lifelong Learning Institute

11 Eunos Road 8

Singapore, Singapore 408601


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Event description


We keep it simple! Planning a smooth transition starts with understanding the new standard.

Event Details

This full day workshop is designed to equip participants with the fundamental knowledge of the
ISO 13485:2016 through in-depth clause by clause explanation by Mr Bayu Darmawan, who is a Lead Trainer and Auditor for ISO 13485:2016 standard.

Who Should Attend
Professionals in Quality, Regulatory, Executive Management, Manufacturing/Operations, R&D, Product Development, Supply Chain of medical technology companies still planning their transition, medical technology startups, spin-offs, companies aspiring to be in the medical technology industry, and technology transfer offices.

What will I learn?

Overview of ISO 13485:2016 standard

  • Summary of the differences between ISO 13485:2003 and ISO 13485:2016
  • High level comparison with FDA QSR

Day 1 Schedule

Lecture 1: Regulatory Framework
  • Transition period for certificates
  • EN ISO 13485:2016 and the MDD
  • The new QMS audit findings/non-conformance grading system
  • Implications of the EU's Medical Device Regulations

Lecture 2: Management Responsibility
  • Quality Policy and Objectives
  • Responsibility and Authority
  • Internal Quality Audits and Management Review

Lecture 3: Resource Management
  • Competence and Training
  • Infrastructure
  • Work Environment and Contamination Control

Lecture 4: Design and Development
  • Design Planning
  • Design Inputs and Design Outputs
  • Design Verification and Design Validation
  • Design Review
  • Design Transfer
  • Design Changes
  • Design Files

Day 2 Schedule

Lecture 1: Supplier Management
  • Selection, Purchasing Information
  • Written Quality Agreements
  • Purchased Product Verification

Lecture 2: Product/Service Realisation Process
  • Production Control
  • Installation and Servicing
  • Identification and Traceability
  • Control of Nonconforming Product

Lecture 3: Process Validation
  • When to Validate
  • Validation Requirements
  • Software Validation

Lecture 4: Monitoring and Measuring
  • Control of Equipment
  • Processes and Products
  • Data Analysis
  • Complaint Handling

Lecture 5: Corrective and Preventive Action
  • Corrective Action
  • Preventive Action

Trainer's Profile

Mr Bayu Darmawan has more than 20 years of experience in the management system Consultancy and Auditing in the areas of Quality, Health & Safety, Environment, Energy, Medical Devices, Telecommunication and Integrated Management System.

  • Registered Management Consultant with Institute of Management Consultants (Singapore).
  • Royal Melbourne Institute of Technology Australia, Master of Engineering in Quality Management.

  • Audited Industry sectors included electronics, oil and gas, chemical, mining, telecommunication, medical devices, construction, machinery, transportation & logistics and trading.

  • Previously assumed the post of Operations Director for BSI Group Singapore Pte Ltd, an internationally accredited Certification Body.

  • Lead Trainer for Lead Auditor training in Management Systems.

Course Details
Date: 19 to 20 October 2017
Time: 9am to 5pm
Course fee: $950*

What is included: Training materials, Lunch, Refreshments and Certificate of attendance.

* Discounts will be given for registering 5 or more participants.

Mode of Payment
Cheque payment issued to ‘Antrise2c International Pte Ltd’ with the invoice number indicated behind the cheque. Please make the course fee in full at least 7 days before class commencement.

Cash payment can be made during our office hours (Monday to Friday @ 9:00am to 5:00pm) or on the day of training.


Please contact our Event Co-ordinator, Ms June Ng @ to find out for more information.

You may also wish to contact the following personnel via phone:

  • Bayu Darmawan (HP no. 9040 0166)
  • Louis Wong (HP no. 9001 7482)
  • June Ng (HP no. 8721 8985)

Antrise2c International Pte Ltd
60 Paya Lebar Road
#09-38 Paya Lebar Square
Singapore 409051
Telephone no. (65) 6678 7653

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Lifelong Learning Institute

11 Eunos Road 8

Singapore, Singapore 408601


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