Medical Devices
Regulatory compliance infrastructure, clinical data management, and global distribution systems built for medical device companies on AWS.
Medical device companies face some of the most demanding regulatory requirements in any industry, while managing complex global supply chains and sensitive clinical trial data. Cloud Life Consulting builds AWS infrastructure that meets FDA, CE, and international medical device regulatory requirements without slowing down product development or global expansion.
By the numbers
21 CFR
Part 11 and EU MDR compliant infrastructure for clinical data and regulatory submissions on AWS
99.99%
Uptime achievable for medical device connectivity platforms and clinical data systems on AWS
ISO 13485
Aligned quality management data infrastructure with audit trails and CAPA tracking on AWS
What we build for you
21 CFR Part 11 and EU MDR compliant data management with immutable audit trails and e-signatures on AWS
Connected device data pipelines using AWS IoT Core for real-time clinical and operational device data
Global distribution and regulatory submission data management with regional compliance controls on AWS
ISO 13485 aligned quality system infrastructure with CAPA tracking and change control on AWS
Generative AI on AWS
Cloud Life helps medical device companies deploy Amazon Bedrock and SageMaker for automated regulatory document preparation, device performance anomaly detection, and clinical outcome analysis.
Cloud Life builds compliant AWS infrastructure for medical device companies managing regulatory requirements, clinical data, and global distribution at scale.
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