Expert support services

Consulting help when and how you need it... at all lifecycle stages of product development

Fixed Price Consulting Packages

No surprises....only results. Value-add deliverables from our expert certified consuting partners.
Regulatory Strategy Analysis
Insight in to submission pathways, classification, and regulations required to bring your product to market.
Preliminary Hazards Analysis
Jumpstart your risk analysis activities with  moderated hazards generation discussions.
Quality System Validation
Make your QMS official by performing official validations required for compliance.
Q-Sub Meetings with FDA
Get FDA's feedback on your regulatory pathway and overall strategy with a face to face meeting.

Our certified experts provide a wide range of support

No matter how good your tools are and training are, sometimes you still need an expert's help to navigate in a compliant space. Nemedio offers access to pre-vetted Regulatory and Quality experts who can guide you at any step of the device development process.

Regulatory strategy
Software Design & engineering Compliance
Design to Manufacturer Transfer
Clinical Testing
Usability & Human Factors
Training Curriculum Development
Risk Management

IEC 60601 Adherence & Collaterals
Post-market Surveillance

Support at any step of your process

Hit a wall in your regulatory strategy planning? Or need help auditing a new supplier? Our team of nemedio certified consultants can help.

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