Regulatory1 is a Regulatory, Compliance and Technical Consulting firm which offers quality solutions to customers in the Medical Device Field.
We offer a unique "One Stop Shopping" approach supporting medical device manufacturers to achieve compliance with global regulatory requirements.
Our In-housing expertise on determining the appropriate global regulatory market entry strategy and can support in preparing submission files which comply to specific local regulations.
We continuously focus on the quality resources and will deliver out
services & consultation with integrity and professionalism.
To be a renowned company, catering to a wide customer base, to continually strive towards offering the best quality in Consultation and Testing Solution.
Regulatory1 will strive to be reliable and trusted partners and will earn respect as a preferred partner. Total Customer Satisfaction and Compliance to Regulatory requirement is the ultimate goal for Regulatory1 and we will work towards achieving our goal.
Regulatory1 is a Regulatory, Compliance and Technical Consulting firm which offers quality solutions to customers in the Medical Device Field. We concentrate on providing the gap assessment, product development, compliance with Standard requirement and strategy to reach the market in compliance to Regulatory Requirement.
Regulatory1 provides complete one Stop solution support for Medical Devices and IVD manufacturers and startup companies. With our international team of specialists, we pave the way to a CE mark for the European market as well as the international registration of your medical devices. you can only sell products that have been approved!
The initial management team depends on the proprietor, with a few highly skilled employees.
Uncompromising attitude for truth and integrity in meeting business needs Without compromising.
We want to express our appreciation for QMS guidance and assistance in helping usachieve.
3D Bio-Plotted Composite Scaffold Made of Collagen
Quick/effective decisions for addressing customer needs
Total Transparency in our dealings with our customer
ISO13485:2012, Medical devices– Quality management
