"Navigating Compliance, Ensuring Your Success in the Canadian Market"
Navigating the complexities of Health Canada medical device approval can be daunting. Our expert team offers extensive support and consultation to streamline the approval process for your medical devices (including in vitro Diagnostics Devices). We offer thorough guidance on regulatory requirements, assist in preparing and submitting all necessary documentation, and facilitate effective communication with Health Canada.
Our mission is to provide you with the critical information and guidance needed for market placement, claims, and regulatory compliance. This empowers your company to earn customer trust, boost profitability, and excel in the highly competitive marketplace.
Our Services
Regulatory Strategy and Consultation
Provide expert guidance on regulatory pathways, submissions, and compliance strategies for Canadian Market.
Navigate complex regulations of Health Canada for Medical Device License (MDL) Application.
Regulatory Submissions Support
Prepare, review and submit regulatory documentation to Health Canada for Medical Device License Application for Class II, III, IV devices.
Ensuring compliance to regulatory requirements and assisting in MDEL application for Class I medical devices.
Classification, Labeling and Design Control
Assist in product classification according to Health Canada regulatory requirements.
Develop compliant product labels, Instructions for Use (IFUs), and packaging inserts.
Consulting for product design & development and Assist in significant design change impact assessment
Testing Requirements and Safety Assessment
Discover the testing essentials for your device, including biocompatibility testings, electrical safety testings, and clinical evaluations, receiving guidance on the precise safety and performance standards best suited to its specific type.
Gap Analysis
In-depth assessment of your current technical documentation, and compliance practices against the relevant regulatory standards.
Identify deficiencies in Technical Files, DMRs, DHRs, and labeling.
Develop a tailored plan to bridge gaps.
Risk Assessment and Mitigation
Implement risk management processes based on ISO 14971. Identify, assess, and mitigate risks associated with medical devices.
Develop risk management plans to ensure product safety and regulatory compliance.
Post-Market Support
Provide support to implement processes for post-market surveillance, complaint assessments, CAPA, Incident Reporting and Medical Device Recalls.
Provide comprehensive review of promotional/marketing materials and website contents in compliance with Health Canada regulatory requirements.
Connect With Us Now
We are eager to collaborate with you on your regulatory needs. Connect with us today for tailored solutions designed to meet your unique requirements.