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Understanding the regulations regarding your medical device software or app is challenging with limited information available to developers. With the EU regulatory landscape changing, it is important to know which laws and regulations apply to your software to ensure optimal route to market. Intended as the first of three courses, over 4 modules you will gain a solid understanding of the European regulatory requirements that affect not just mobile phone apps, standalone software or cloud computing services but also artificial intelligence, firmware for medical devices and plugins that run on consumer electronics or on platforms part of the Internet of Things. By the end of this course you will be able to navigate the EU regulations and identify which ones are relevant to your product.
Suitability - Who should attend?
This is an introductory course applicable to people working in medical software and health app development and regulations. Departments include:
- Regulatory Affairs
- Software Developers
- Software Engineers
- Medical Device Developers
Training Course Content
- Determine whether your software or app is a medical device under the current definitions
- Learn definitions of various software and apps including: standalone software, mobile applications, IVDs, active implantable
- Familiarise yourself with the current classification system for medical devices, and know which class your software belongs in
- Understand the EU Regulatory landscape, and know how to navigate these regulations and identify which ones are relevant to you
- Assess the various routes to market for a software/app when it is a device: CE marking, Notified Body, conformity assessment.
PTI - Pharmaceutical Training International - Training for the Pharma Industry
PTI is the global leader in professional education for the pharmaceutical industry, delivering a broad course portfolio that covers the industry spectrum: R&D, Clinical Development, Generics, Bio-pharmaceuticals, fine Chemicals, Agro-chemicals, Medical Devices, Animal Health, Manufacturing and Regulations. PTI's open courses,...
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