Your Strategic Partner in Medical Device Compliance
We are a team of dedicated practitioners providing specialist support to help you navigate complex regulations, perfect your compliance documentation, and accelerate your time-to-market.
A Partnership for the Full Product Lifecycle
Our services are designed to provide expert support at every critical stage of medical device development and post-market activities.
Risk Management (ISO 14971)
We deliver comprehensive, audit-ready Risk Management Files, including plans, reports, FMEAs, and hazard analyses to ensure product safety and compliance.
Quality Management Systems
From gap analysis to full implementation and audit preparation (ISO 13485, 21 CFR 820), we ensure your QMS is robust, compliant, and efficient.
Regulatory & Design Controls
We provide expert support for Design History Files (DHF), technical documentation for CE Marking, 510(k) submissions, and usability engineering (IEC 62366).
The Practitioner's Advantage
We Bridge the Gap Between Theory and Practical Application.
Our firm is founded on over six years of dedicated, in-the-field experience as Risk Management Engineers. We haven't just studied the standards—we've implemented them. We've built the Risk Management Files, authored the FMEAs, and faced the auditors. This hands-on experience means we provide solutions that are not only compliant but also practical, efficient, and tailored to your specific product and company stage.
Our Foundation
Anil Sharma Kandel
Founder & Principal Consultant
A Clear Path to Compliance
Our process is collaborative and transparent, ensuring we meet your goals effectively and efficiently.
STEP 1
Discovery & Scoping
We start with a deep dive into your products, processes, and specific challenges to define clear project goals, deliverables, and timelines.
STEP 2
Strategic Execution
Our experts perform the hands-on work, from drafting documents to analyzing data, with regular check-ins and transparent communication to ensure alignment.
STEP 3
Review & Handoff
We conduct a thorough review of all deliverables together, ensuring your team is fully equipped and trained to own and maintain the new processes and documentation.
Ready to Fortify Your Compliance and Accelerate Your Growth?
Let's have a conversation. We are available to discuss your specific needs. Whether you need urgent support for an audit or strategic guidance for a new product, we're here to help.
Get in Touch
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