778-751-8127 info@silosa.ca

Regulatory Services

Get In Touch

US FDA Agent Services for foreign companies

US Agent services for foreign companies at lowest fee. US Agent plays important role for regulatory communication.

Regulatory Submissions for Medical Devices

Determining what regulatory will be required for your medical device is to properly classify your medical device. Medical Devices in both the United States and Canada are classified based on risk, with regulatory oversight increasing with each class.

Canada & USA, EU (Europe Union)

FDA

US Agent appointment is a mandatory requirement for foreign companies to register with the FDA. US Agent acts as a point of contact for the FDA to communicate with foreign companies. 

Health Canada

The Medical Devices Bureau of the Therapeutic Products Directorate (TPD) is the regulatory body responsible for licensing Medical Devices in Canada.

Europe Union (MDR)

New MDR Registration and transition consulting from MDD to MDR 

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Our Vision

Upgrading Implementation of  (ISO) Management System Standards, Training programs empower young people with skills, knowledge and providing a great framework of standardization worldwide by implementing encouraging programs for recognizing National Industrial, agricultural products and services at Regional and International level.

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Our Mission

  • Publication high level international Training Books
  • Implementing Train & Employment programs (TEP) worldwide
  • Management Consultancy to the Government’s projects
  • Upgrading Quality and standardization
  • Special Consideration to HealthSafety and Environment

Stats

SCG By the Numbers

Silosa Consulting Group Inc. activities and experiences in more than 25 countries :

ISO 14001

ISO 9001

ISO 13485

Other Standards

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Silosa Consulting Group Inc. offers outsourcing services for various Management System  functions such as:

Supplier onboarding assessment, 

Product Certification Audits

Management System development and Continuous performance monitoring

SCG can perform  Pre-assessment, Assessments of Audit, Internal Audits

SCG can execute continual improvement activities to assist organizations

Our Office

Parkway Blvd.,
Coquitlam, BC V3E3K5, CANADA

Contact Us

+1- 778 -751-8127
info@silosa.ca 

Office Hours

Mon-Fri: 9am – 5pm
Sat-Sun: Closed