Navigating the Regulations for Health Apps and Medical Device Software
Navigating the regulations that surround health software products and services is challenging with little information available to developers. It is important to understand which laws and regulations apply to you and remain up to date with their changes. 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. You will learn which requirements are relevant to your software products and services and be in a better position to know the optimal route to market them.
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
Outcome / Qualification etc.
- 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.
Training Course Content
- Module 1: Is it or is it not a medical device?
- Module 2: What class does your medical device software have?
- Module 3: Route to market medical device software (Europe)
- Module 4: Other regulations that may apply to health software products (Europe)
Why choose PTI
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Quality of content:
85% had applied content during the course to their role
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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