RLS PHARMA SERVICESRLS PHARMA SERVICESRLS PHARMA SERVICES
+1 (204) 296-4449
info@rlspharmaservices.com

Medical Devices

Our Services Include:

Regulatory and strategic planning
Audits of foreign and Canadian facilities
Medical Device Establishment facility design
MDEL set up consultation and customized training
MDEL Attestations
Writing Standard Operating Procedures (SOP’s) and Quality Manuals
Guidance on Medical Device site Establishment Licenses (MDEL) process and inspections
Liaison with Health Canada and International Regulatory Authorities for Inspections, audits and submissions
Pre-inspection preparation and planning
Manage and attend Health Canada Inspections
Prepare post-inspection corrective action responses
Complaints and Mandatory Problem Reporting
Guidance on Medical Device License (MDL) Submissions/applications
Application support during regulatory review
Label and advertising review
Guidance on regulatory compliance issues
Let’s Get Started

Are you ready to work with our compliance specialists?