Medilink members Educo Life Sciences, learning, and development specialist providing technical training solutions to the pharmaceutical, biotechnology, and medical device industries. Offer a series of workshops tailored to the life sciences, focused on improving the skills and knowledge of life science professionals, so they perform with confidence, accelerate their careers, and drive innovation.
Medilinks discount code
Medilink members are eligible for a 50% discount on all medical device courses.
About Live Online Courses
Typically delivered over two weeks the learning material is divided up into bitesize modules. Each module is delivered live using webinar technology, creating a virtual classroom learning environment. Live sessions provide you with direct access to the trainer so you can ask questions, understand complex concepts and share ideas with peers.
More information – https://educolifesciences.com/live-online-training/
Benefits of a live online course – https://youtu.be/kRtDOH1QRis
|Educo home Page||https://educolifesciences.com/|
|Medical Device and IVD training home
|Medical Device Regulatory Training||https://educolifesciences.com/medical-device-regulatory-training/|
Medical Devices: Brexit and the UK Responsible Person
This short training course examines the latest Brexit device regulations and guidelines to ensure your product is compliant on the UK market. You will examine the UK conformity Assessment and the UKCA mark, comparing it the CE mark. Once completed, you will have also a comprehensive understanding of the UK responsible Person and the product registration requirements so you can plan your regulatory strategy.
Fundamentals of the EU Medical Device Regulation (MDR)
This online course will provide you with a comprehensive understanding of the EU MDR requirements from device classification and conformity assessment routes to clinical requirements and post market factors. By examining a broad range of topics, you will develop a deep knowledge of the MDR and its impact throughout device development and distribution. This course has been specifically designed for those new to Medical Devices, the MDR or experienced professionals changing roles.
Fundamentals of the EU IVD Regulation (IVDR)
This online course provides you with a complete overview of the IVDR from economic operators and classification to working with a Notified Body and understanding conformity assessment routes. You will examine the key clauses of the new IVDR and its implementation on Europe. Once completed you will have the knowledge, skills and tools to carve out a transition strategy, ensuring your IVD product(s) remain compliant.
Labelling and UDI for Medical Devices and IVDs
This online Medical Device and IVD labelling training course will develop your knowledge and skills so you have the confidence to navigate the latest requirements. You will examine major new elements such as UDI requirements, label requirements and how the label is related to the EUDAMED database, PMS and risk management. Once completed you will have the ability to develop strategies to transition smoothly to the new requirements under the MDR and IVDR.
Implementing ISO 13485:2016 and MDSAP
This online training course will look to provide you with the processes to ensure you implement and comply with ISO 13485. You will learn the concepts needed to understand, develop and implement a quality management system (QMS). You will also gain a complete over of the MDSAP and how to prepare your quality system for MDSAP compliance.
Gathering Clinical Evidence for Medical Devices
This interactive online course focusses on all aspects of clinical evidence. You will examine the latest requirements and guidance available to ensure that you collect the right type of evidence and sufficient evidence for your medical device. You will learn about the clinical evaluation process, clinical investigations and post market clinical follow up studies and data collection. You will also cover specific clinical documents including the clinical investigation plan, clinical investigation report, clinical evaluation plan, clinical evaluation report, clinical development plan, summary of safety and clinical performance as well as post market clinical follow up plans.
Implementing ISO 14971 Device & IVD Risk Management
This training course on ISO 14971:2019 will provide you with a comprehensive understanding risk management. Applicable to device and IVD professionals, you will learn a variety of tools and techniques to use on your own risk management strategy. Crucially, you will understand how risk management impacts other regulatory areas such as quality (ISO 13485), PMS, clinical and usability (EN ISO 62366).
Understanding Biocompatibility for Medical Devices
This training course will provide you with a comprehensive understanding of biocompatibility and ISO 10993. You will understand how biocompatibility relates to risk management and safety requirements in the EU (MDR) and US (FDA). Once completed you will understand the biological evaluation process, testing end-points and material characterisation.
Medical Device Software Requirements: A Regulatory Overview
This training course will provide you with solutions to the regulatory challenges you face when working with software as a medical device. Once completed, you will have the knowledge to know what must be done to meet Notified Body/ Regulatory requirements. You will briefly touch on aspects unique to software in major regulatory/development areas such as clinical evaluations, investigations, labelling, post market surveillance and risk management.