ISO 14971 - Consulting & Implementation for Medical Software (SaMD)
What we offer
Clear and understandable implementation of risk management standard ISO 14971
The logical connection of the Risk Management File with the rest of the Technical Documentation
Practical training and guidance on techniques such as:
Preliminary Hazard Analysis (PHA)
Design Failure Mode Effect Analysis (DFMEA/FMEA)
Risk Assessment
Risk Evaluation
Risk Control Measures implementation and verification
Why Work With Us
Our team has extensive experience with U.S. regulatory submissions and understands the nuances of FDA requirements.
We have successfully supported multiple 510(k) submissions and other regulatory filings for medical devices.
We ensure that your design and documentation processes are efficient, practical, and aligned with FDA regulations.
Our experts are well-versed in aligning cybersecurity and software development practices with the FDA’s expectations for connected devices.
We simplify the complex FDA compliance process, ensuring that your team is confident and well-prepared for audits or reviews.
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