Regulatory Services
Get In TouchUS 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 Health, Safety 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