LOGISTICS      •       PLANNING       •     DEVELOPMENT       •      MANUFACTURING        •       DISTRIBUTION 

REGULATORY

In parallel with the development phase, we will make sure you have the appropriate documentation, registrations and classifications to meet your industry's standards, allowing your product to reach your consumers with confidence.

Some of the ways IV Thought can help with regulatory

• FDA Registration and Listings.
• Device Classification.​
• Technical Writing (Technical Files, Risk Assessments, Hazard Analysis, PFMEA, DFMEA, Biocompatibility, Procedures, SOPs, and Work Instructions).​

• ​Clinical Evaluations (reports, protocols, consent documents, IRB applications).
• CE Marking Documentation and support.​
• Corrective and Preventive Actions with Effectivity.
• ​Training Programs.​​

• Quality Management System development (ISO 13485:2016, ISO 9001:2015, FDA,QSR).
•  Internal Auditing.
•  International Registrations and Certifications (including product safety certs).
• Environmental Compliance (RoHS 3, REACH, China RoHS, Green Passports, Prop 65, Conflict Minerals)

A TO Z, WE PROVIDE A COST EFFECTIVE AND COMPREHENSIVE 
SOLUTION THAT WILL MAKE YOUR PRODUCT A REALITY

LET'S TALK