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.
Contact us for Complete Risk Management of your IoMT.
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.
SaMD – Software As a Medical Device.
AlaMD -AL As a Medical Device.
Risk management (ISO 14971:2019) for Local connection to the main product and Network connection to another device or server.
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).
Operating without an EU Entity?
You could be at risk of a Product recall, Penalty or legal action!
When it comes to medical device manufacturing, patient safety depends on the quality and consistency of medical products.