Quality Performance Improvement
Training Synopsis
This training is designed to provide a working understanding of the major features of the Medical Devices Directive and comparisons to the new Medical Device Regulation, including terminology, product classification, conformity assessment routes, and Technical Files, including the Essential Requirements.
Introduction
Learning Objective
Duration
Methodology
Target Participants
Course Outline
Training Certificate
Why Us?
Introduction
European Union (EU) Directive 93/42/EEC (also known as the Medical Devices Directive – MDD) specify the Essential Requirements that manufacturers and importers must meet to apply for CE marking. Seller shall consider relevant directives to legally market or sell their devices in the EU.
This training provides a working understanding of the major features of the Medical Devices Directive and comparisons to the new Medical Device Regulation, including terminology, product classification, conformity assessment routes, and Technical Files, including the Essential Requirements. Changes of the directives will be discussed.
Other relevant legislation such as new Medical Device Regulations and implementation timelines will be discussed.
Learning Objective
By the end of the training, participants would be able to:
- Describe the ISO 9001: 2015 requirement with aids provided
- Describe a proper approach to conduct gap analysis
- Describe the process to determine the gap and reporting these gap
- Determine action plan to address the gap.
Duration
Duration proposed at quotation.
Methodology
Training session includes classroom lecture, exercises, group work and discussion.
Target Participants
Certificate of Attendance will be issued to participants who fully participated the training and satisfied the attendance requirements.
Course Outline
- EU medical device regulatory overview
- Legislative structure relevant to MDD
- EU pre-market regulatory requirement
- EU medical device post-market regulatory requirement
Training Certificate
Certificate of Attendance will be issued to participants who fully participated the training and satisfied the attendance requirements.
Why Engage aNTS / Peplow-Warren?
Peplow-Warren Consultant Team is formed by a group of experienced sector expert, certification auditors, consultants and industry practitioners. They actively involve in international standard and specifications development by acting as active ISO and MOSTI Technical Committee Member. They carry a common mission: they are willing to share their good knowledge with current industry practitioners. Call us today for more detail. We are obliged to work together and grow your business.
Investment
Contact our Customer Care Hotline 012-713 3356 / 011-2128 4750 or email to ntsask@gmail.com / sales@peplow-warren.com for your best solution and offer.