Digital Health

TIME CRITICAL SERVICES

Are you developing a SaMD/ALaMD?

Looking for Regulatory support?

Look no further!

From Standard Compliance to EU/USFDA Submissions, we shall be your regulatory risk partners!

Do you have many components associated with your Digital Innovation and are not sure of the risk associated with it?

Do not worry!

Our Experts got you covered.

The future of MedTech walks on a double edge sword where Cyber Security poses the highest threat.

Why expose your end-users, digital health innovation to cyber threats?

Our Experts are here to guard your innovation!

From programs to applications, we will ensure complete regulatory compliance of your digital creations in the Medical world.

We provide a wide range of services including:

Standard Compliance – evidenced-based reviews for Digital Health and Mobile phone apps.
Good software practice – Software compliance to the appropriate regulatory standards.
SaMD – Software As a Medical Device.
AlaMD -AL As a Medical Device.
Defining Machine Learning and Artificial Intelligence in the Medical World.
Design and Development Practice.
Technical Documentation (File) or 510K submission.
Managing EU RED Radio Equipment Directive
Demonstrating compliance for Electrical and EMC safety Application-Specific advice.
Regulatory Guidance for LPBT (Low Power Bluetooth) and wireless communication.
Risk management (ISO 14971:2019) for Local connection to the main product and Network connection to another device or server.
Cloud Management.
Managing and protecting Personal Data and Patient Information on Digital Platforms.
Regulatory GAP Analysis report for the EU/USA/UK markets
Cybersecurity Risk Management
Cybersecurity Threat Analysis.
Total Product Life Cycle Report.
Management of Digital Supply Chain.

Rest of World regulatory and quality compliance expertise is provided by our parent company, Global Regulatory Services (GRS).