The date of application of Regulation (EU) 2017/745 on medical devices is approaching and the European Commission has issued new and updated guidance documents. Please find below a list of the corresponding papers and let us know should you require a copy: – Factsheet for Class I Medical Devices – What You Need to Know…
Legacy devices are products that have been CE marked in the context of the current Directives but not under Regulations (EU) 2017/745 and 2017/746 on medical devices or in vitro diagnostic medical devices (MDR and IVDR) respectively. The Management of Legacy Devices, published by the European Commission, explains how and when legacy devices will be…
Design and Development Requirements for Medical devices Training – CEMB On March 29-30, 2021, Parivat Akarapimarn, Senior Consultant, participated as a speaker in the training of “Design and Development Requirements for Medical Devices” in collaboration with Center of Excellence on Medical Biotechnology (CEMB). The aim of this 2 day special training program is intended as…
COURSE OUTLINE The FDA Quality System Regulation, 21 CFR Part 820, ISO 13485:2016 and Medical Device Single Audit Program (MDSAP) contain significant requirements in relation to design and development (design control). In many cases manufacturers have not satisfactorily established compliance with the regulation and standard and have received adverse inspections, including issuance of FDA Warning…
COURSE OUTLINE Practical workshops throughout the day are also provided in order to give you the opportunity to apply your skills how to implement risk analysis, risk evaluation, risk control, production and post-production activities and risk management review within your organization. This fully 2-day course is a highly interactive training that includes case study exercises,…
COURSE DESCRIPTION The Medical Device Single Audit Program (MDSAP) allows medical device manufacturers to meet regulatory and quality system requirements in multiple markets through a single audit. Current MDSAP members include Australia, Brazil, Canada, Japan, and the United States, and others are expected to join as the program matures. MDSAP has been required by Health…
COURSE DESCRIPTION Implementation of European Medical Device Regulations is the primary requirements while demonstrating the compliance to regulatory requirements while placing the products in European Market for the Medical Device manufacturers and to place CE marking on the products. The European Council Directives 90/385/EEC and 93/42/EEC has been revised to Regulation (EU) 2017/745. European Medical…
AGENDA DAY ONE Morning Session 09:00 – 09:30 Module 1: Overview of Worldwide Medical Device Regulations (United States, Japan, Canada, Europe, ASEAN) 09:30 – 10:30 Module 2: Overview of ASEAN Medical Device Directive (AMDD) Definition of medical device acc to AMDD and Thailand Medical Device Act Classification of Medical Devices 10:30…
COURSE OUTLINE This 1 day special training course “Corrective and Preventive Action” is intended as an introductory course to enable participants to have: Basic understanding of corrective and preventive action principles according to relevant regulatory standards Root cause analysis and corrective and preventive action taken Audit case studies to develop skill for identifying the root…
COURSE OUTLINE This 1 day special Quality System Regulation training program is intended as an introductory course to enable participants to have a basic understanding of US FDA Quality System Regulation, Quality System Inspection Techniques (QSIT) approach. Moreover, participants will be provided with tips for handling inspector during FDA inspection as well. Who Should Attend…