The Medical Device Coordination Group (MDCG) has endorsed a document on the topic of clinical investigation application/notification since EUDAMED module for clinical investigations is not yet functional. The sponsor of a clinical investigation is required to submit an application / notification to the Member State(s) in which a clinical investigation is to be conducted, accompanied…
Singapore’s Health Science Authority (HSA) has announced that they will follow many countries example and begin implementing a Unique Device Identifier (UDI) system. UDI is an international system for identifying Medical Devices (MDs) meant to help quickly identify people affected by product recalls, device failures, or serious adverse events. UDI has been adopted by the…
Eurofins Expert Services Oy of Finland is the latest European Notified Body designated under the Medical Devices Regulation (EU) 2017/745 (MDR), before the Date of Application (DOA) on May 26, 2021. It has been listed in the NANDO database and assigned a Notified Body number of 0537. This brings the total number of Notified Bodies…
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…