Expert support services
Consulting help when and how you need it... at all lifecycle stages of product development
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.
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.
Software Design & engineering Compliance
Design to Manufacturer Transfer
Usability & Human Factors
Training Curriculum Development
IEC 60601 Adherence & Collaterals
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.contact us