This In-house course provides a detailed introduction to the European medical device legislation. It will explain the Regulation and which products are covered, the involvement of Notified Bodies, how to choose one and outline what a manufacturer must do.
This one-day In-house training programme will provide your team with a practical guide to the foundations of effective technical writing and editing and apply them to your role in the workplace.
This In-house course will provide a solid foundation in the approval and clearance processes for medical devices in the United States including the underlying legal and regulatory requirements and the ‘general controls’ applicable to all devices.
This one-day In-house course has been designed specifically for product developers who want to incorporate human factors testing into their product development, or need to provide the regulators with specific usability data for their device
In this In-house course provides a comprehensive overview of the requirements of ISO 13485
A comprehensive In-house course of medical device regulatory affairs in Russia and the Eurasian Union. Key countries covered include Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan and Ukraine.
This In-house course will provide an essential overview of the key areas of requirements for product approvals for medical devices in the Middle East.
This In-house course provides an Introduction to Medical Device Software: Regulations & Requirements to include EU & FDA Guidance and Risk Management
This In-house course has been designed specifically for those who are involved in gathering clinical evidence required for medical devices and in-vitro diagnostic products.
This In-house course gives an essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow up requirements and adverse event and vigilance reporting.
This In-house course manages the transition to the new regulation.
This In-house project management course has been designed specifically for the Bio/Pharma Industry and is also applicable to those in medical device and animal health industries. It will provide your team with a thorough understanding of project management skills, including both technical and interpersonal skills.