Industry Expert Learning Series HRDF SBL Claimable
Risk Management for Medical Devices (EN ISO14971:2012)
This course covers the techniques of risk management ISO14971:2007 and the expectations of European regulations in applying risk management for medical devices.
INTRODUCTION The EN ISO 14971:2012, application of risk management to medical devices, is a framework for effective management for medical device manufacturer to address the risks associated with the use of medical devices. The requirements that it contains provide a framework within which experience, insight and judgement are applied to manage these risks. The ISO 14971 is necessary for the manufacturers to make judgments relating to the safety of a medical device, including the acceptability of risks, taking into account the generally accepted state of the art, in order to determine the probable suitability of a medical device to be placed on the market for its intended use/intended purpose.
COURSE OBJECTIVES This training aims to provide participants with a clear understanding and insight into the ISO 14971 – application of risk management to medical devices and identify the hazards associated with medical devices and their accessories, estimate and evaluate the risks, control these risks and monitor the effectiveness of the control.
Risk Management - Objective
Risk Management as established in EN ISO14971:2012
General requirements for risk management
Types of Risk Analysis Techniques
How to implement according to EN ISO14971:2012
Risk evaluation process
Annex D of EN ISO14971:2012 (Risk Concepts applied to medical devices)
Table ZA.1 – Correspondence between Directive 93/42/EEC and ISO14971
Exercise: Example of how to comply with the Directive.
TARGET AUDIENCE Professionals directly involved in regulatory affairs, quality assurance, process development or manufacturing. Quality managers, quality engineers and quality technicians involved in the development and manufacturing of medical devices. PRE-REQUISITES Basic understanding of the Medical Devices Regulations, ISO 13485 2016 and basic understanding of Design and Development Control is preferred. Previous knowledge of ISO 14971:2007 not required.
DURATION : Two (2) full days
PAYMENT Payment is required before/ on training date. Please choose from below options.
Option 1 : Direct Bank-in or via E-Banking upon receipt of Invoice Please note that any Early Bird Discounts (for registration within validity period) will be reflected in the invoice.
Please refer the following bank account details: Beneficiary Name: Medsociate Sdn Bhd Bank Account Number: 800 3930 348 Bank: CIMB Bank Swift Code: CIBB MYKL
Please email us (firstname.lastname@example.org) the bank-in slip / remittance slip once the payment is made.
For Government Sector A Local Order (LO) or letter of approval to participate must be presented before the training.
Option 2 : Direct Online Payment You can choose to make payment via Paypal upon receipt of invoice. When making payment, in the email section, please key in our Paypal Account : email@example.com
SUBSTITUTION Substitution is allowed for a registered participant. No refund will be made for cancellation.
CANCELLATION Medsociate Sdn Bhd (AMMI Authorised Training Provider) reserves the right to cancel or postpone any training or event but with due notice to the registered participants / company(s). Any payment made will be refunded if the cancellation is made by training provider. Cancellation of attendance and refund will not be entertained as all bookings would have been reserved and confirmed.
CONTACT 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