Industry Expert Learning Series HRDF SBL Claimable
Establishing and Maintaining Technical Files and Design Dossiers for EC Certification
DURATION : Two (2) full days INTRODUCTION For EC Certification (i.e. CE Marking) purposes the Technical File construction is subject to review by a Notified Body if the medical device is Class I with measuring or sterile function, Class IIa, IIb, and III (Design Dossier). Once placed on the market, national Competent Authorities has, at any time, the right to review EU Technical Files regardless of device risk classification.
COURSE OBJECTIVES This course provides the essential understanding on how to assemble this information and present the information properly. An incomplete or improperly completed Technical File may result in unexpected delays or even prevent market entry. Improperly maintained files will result in major noncompliance issues which may even lead to certification suspension as well as market withdrawal. Technical files are retained on the premises of the manufacturer or the Authorized Representative for potential review of Competent Authorities and Notified Body.
Understand the differences between the Technical File and Dossier and impact on contents of these documents
Compile the EU Technical File or Design Dossier and ensure Format and Contents are in compliance with EU requirements
Understand why Design Dossier is viewed as a subset of the Technical Documentation with emphasis on “design”.
Determine exactly what information needs to be compiled and presented.
Understand the EU Notified Body process on issuance of EC design-dossier certificate.
Review all existing documentation in support of meeting the applicable Essential Requirements of the Directive(s).
Determine applicable standards and address company-specific SOPs for establishinf and managing your Technical Files.
Determination on the usage of International, Regional & National Standards as well as other documents supporting Technical Files and Design Dossiers.
Recognise EU Guidance’s on Technical Documentation, Clinical Data and associated Post Market requirements.
Anyone involved in defining, planning, or implementing an ISO 13485:2003-based quality management system
Implementation team members
Those involved in contributing information towards as well as collating information for establishment of technical documentation
PRE-REQUISITE Basic knowledge of medical devices and ISO 13485:2003 would be beneficial.
DURATION Two (2) full days
iNTERESTED TO FIND OUT MORE? For enquiries, please email to firstname.lastname@example.org. Medsociate Sdn Bhd (HRDF Approved Training Provider - Registration No. 4195) (AMMI Authorised Training Provider and Secretariat) Tel: +6010 4040 662 Fax: +603 2178 4347