QA/RA Leader Medical Devices

Course description:

This 3-day tailor-made training is led by experienced trainers and combines theory with reality-based processes. The aim of the training is to make you well equipped and prepared to lead the QA/RA function in a medical device organization, to give you the latest information in the field of medical device regulations and quality system standards and provide a great opportunity to network with other quality managers. When combined with in-depth training in Quality Management system and Medical Device regulations, such as our advance level training course “Medical Quality Management Systems” you are well prepared for the position as QA-RA Leader, and the role as person responsible for regulatory compliance.

The training also serves as preparation for personal certification as QA-RA Leader; Medical Devices. Read more about the certification process at at www.sbq.nu The person responsible for quality assurance and regulatory compliance in a medical device company need both broad and specific knowledge which must be documented. Further, the new EU regulations for medical devices (MDR) and In Vitro Diagnostics (IVDR) requires the manufacturer to appoint a person responsible for regulatory compliance who has specific responsibilities and must show documented evidence of expert knowledge in relevant fields. This training will provide you with valuable tools and knowledge needed for that role.

Course outline

• Medical Device Regulations – Regulatory framework in EU and US, and (briefly) in other markets. The definition of a medical device. Requirements for market access in EU and US. General quality system requirements.
• Role and responsibility of the person responsible for regulatory requirements as defined in MDR/IVDR .
• Quality Management Systems – ISO 13485:2016, interpretation of the standard, how to assess and monitor the efficiency of the quality system. Release/control of a product under a QMS.
• Product Development – The product development process – how to define the start and end of the development phase; demonstrate compliance to the regulations and decide on market release. The role of QA and RA in the development process.
• Product maintenance – how to manage the content of the Design and Development files (DHF) in relation to changes to the product, in the production process and feedback gained from the market (PMS).
• Marketing control – Post-market surveillance (PMS), Medical Device Reporting / Vigilance, Postmarket Clinical Follow-up, Control of Marketing materials.

Learning objectives

After completion of this course you will be prepared to…

• Understand how medical device regulations are designed and expected to be observed.
• Ensure products are in accordance with regulatory requirements before being introduced to the market.
• Maintain product safety when the product is put on the market, by working with an implemented management system, including risk management and market surveillance, which meet the requirements of the regulations.
• Have knowledge and understanding of how accident and incident reporting is supposed to work.

Who should attend

The training is suitable for quality and regulatory professionals who want to strengthen their competency in medical device regulation and quality management systems, and need documented competency as “person responsible for regulatory compliance”.

It is also designed to serve as preparation for a personal certification as “QA/RA Leader Medical Devices” (read more about the certification at www.sbq.nu.)

Take this training if you:

• are experienced in the role as a Quality/Regulatory Manager or Quality Leader and wants to develop yourself further and get your skills documented.
• need professional development that will benefit both you as individual and the organization.

Prerequisites

Two years’ experience or more of working with quality and regulatory questions in medical device or pharmaceutical industry. Training/knowledge about QSR and ISO 13485 corresponding to the content of our course “Medical Device Quality Management Systems (QMS)”

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