in

Please call 012-588 2728

email to pearl-otc@outlook.com

UNDERSTANDING OF REQUIREMENTS OF THE MEDICAL DEVICE REGULATION 2017/745 (MDR)

This program can be specially tailored and customized to meet your training objectives

Kindly find above attached for the full brochure for this programs

We hope you find it informative and interesting and we look forward to seeing you soon

(SBL KHAS / HRD CORP Claimable Course)

1 Day In-House Program                             By Khairun

OUTLINE

Regulation will affect all medical device manufacturers, importers, distributors and EU Representatives. Subcontractors/suppliers will also be affected, as well as manufacturers of some devices without a medical purpose (for example, devices used for esthetical body modification, contact lenses to change eye colour without correcting vision, etc.).

Among the aspects changed are the classification of products, previous basic requirements, technical documentation, clinical evidence, market surveillance, and quality management systems. The European approval process is uniformly regulated and entails significant changes in terms of organization goals. The new scrutiny procedure, reprocessing requirements, and the introduction of the European database Eudamed also bring about profound changes. In our one-day seminar, you will gain a compact overview to align your company with the new requirements of the Medical Device Regulation (MDR).

OBJECTIVES:

The training provides:

• Overview of the EU MDR 2017/745
• The requirements of EU MDR 2017/745 and other relevant guidance documents
• Working knowledge in application of the requirements
• Preparation and host a product certification

TARGET AUDIENCE:

This course is designed for anyone who may involve in the implementation and execution of this Quality System Regulation, e.g. top management, manager or project member in QM/QA, R&D, design, manufacturing, supply chain, customer service and sales. Knowledge about quality management system for Medical Device Industry (ISO 13485:2016) would be beneficial.

HOW YOU WILL BE BENEFIT:

• Have a good understanding of the expectations of the EU MDR 2017/745
• Assist anyone who may involve in the implementation and execution of this Quality System Regulation
• To Develop your knowledge of how the requirements of EU MDR 2017 / 745 are established and help the organization to fulfil the regulatory requirements
• Feel more confident about an FDA inspection

METHODOLOGY:

• This course can be run in-company around the world
• We can tailor the content to focus on your requirements. 
• This approach makes perfect sense for groups of 4+ delegates, enhancing cost effectiveness as well as team bonding.
• Classroom accompanied by Lectures, real Experience Sharing, Role-plays, Interactive Group Activities, Experiences, Simulation Activities and Feedback
• Delegate manuals and certificates of Attendance will be provided

DURATION:

1 Day (9:00am - 5:00pm)

Outline Of Workshop

ABOUT THE FACILITATOR

MS. KHAIRUN

Qualified auditor for:

• ISO 9001:2015
• ISO 13485:2016
• GDPMD
• MDSAP
• Registered auditor with Malaysia Medical Device Authority (MDA)
• Registered audit for social audit (SEDEX)
• HRDF Certified Trainer

Her latest career: Management System Auditor with a German largest certification body. Audited the following type of medical industries like: manufacturing of rubber:

• 1 manufacturing of suture company,
• 1 manufacturing of cardiovascular graph company
• 3 assembly company
• 4 injection moulding company
• distributors
• 10 authorized representative company · 1 brand owners of the medical device.

Besides that, she also audited for non-medical industries like

• 1 roofing company
• 1 vinyl coated floor company
• 1 construction company
• 1 project management company
• 3 assembly electronic companies in Japan, Singapore and Thailand.

In January 2016, she has been promoted to Product Manager And Responsible to establish, implement and maintain all controls related to compliance with ISO/IEC 17021, related accreditation.

Her existing company was accredited with local accreditation body Department of Standard Malaysia (DSM) against the ISO 17021 and ISO 17065. She leads the team to establish the procedure based on the parent company procedure. After passed through all the hassle, she managed to get her company accredited.

She also managed to help the counterpart in Japan to get their own accreditation by helping them to establish the QMS and give training.

On the other hand, she managed to get the approval from MDA for her existing company to be one of the Conformity Assessment Body with various approved medical code.

She establishes a group of auditors in order to be qualified as MDA auditors. To maintain the continuous personal development of the auditors, she conducted various auditor briefing, auditor exchange and training.

2006 - 2010

She holds the Degree in Chemistry Science from Universiti Sains Malaysia. She developed herself when start growing her career with local manufacturer in rubber industry.

Upon completing her Degree, she started her first occupation with a company  for manufacturing of examination gloves as Quality Executive. During her service, she was responsible to perform internal audit on QMS, in both of documentation and implementation.

She also involved to interface with other departments to compile and determine the required content of quality document for preparation of production Technical File, product specification, product material safety data sheet applicable with EC Council Directives, FDA and other international regulations.

In August 2015, she sat for examination on the Medical Device Single Audit Program (MDSAP) where MDSAP recognized Auditing Organizations to conduct a single audit of a medical device manufacturer that will satisfy the relevant requirements of the medical device regulatory authorities participating in the pilot program. She passed the examination with flying color. On top of that, she went several sanctioned trainings organized by the MDA  and lead  the auditor to do product verification and product conformity in order to get medical device registered with MDA.

We hope you find it informative and interesting and we look

forward to seeing you soon.

Please act fast to grab your favourite training program! Please call 012-588 2728

or email to pearl-otc@outlook.com

Do forward this email to all your friends and colleagues who might be interested to attend these programs

If you would like to unsubscribe from our email list at any time, please simply reply to the e-mail and type

Unsubscribe in the subject area. We will remove your name from the list and you will not receive any additional e-mail

Thanks and Regards,

Pearl.