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Health Canada Will Step in and Halt Your Innovative Medical Device in its Tracks

Imagine getting ready to bring your innovative, game-changing medical device to a Canadian market that is hungry for what you have created, only to be stopped in your tracks by complex Health Canada regulatory requirements. With the right guidance, you can avoid delays and get your product approved fast and efficiently.


Quality Smart Solutions worked diligently and helped with multiple levels including license registration, regulations, and much more. We will always look to Quality Smart Solutions for additional support.
Alexander Fiscalini
ToonOut Ltd.

I've used QSS services for many years now and they always deliver a very professional service. Everyone on the team is great to work with and the always come up with great solutions for your needs at a great price!
Don Gauvreau
Sapro
Adopting the Global Medical Device Nomenclature (GMDN)

Without Preparation, Complex Health Canada Regulations Can Delay Your Launch

You’ve created a life-changing medical device, tested it, have found a market that wants it, but without the proper Health Canada licenses, it gets stuck in development, leaving room for licensed competitors to steal your market share. With its multiple layers of rules and paperwork, the regulatory process can feel overwhelming. You need to move quickly but tackling this alone can lead to mistakes and costly delays.

Quality Smart Solutions Specializes in Simplifying Your Licensing Process

With years of experience in regulatory compliance, Quality Smart Solutions provides clear, expert guidance for your Health Canada medical device license. We handle everything from start to finish, so you can focus on what you do best—innovation.

Here’s how we help:

Clear Classification and Strategy

We determine your device's classification and create a regulatory plan tailored to your needs.

Accurate Application Submission

We prepare your Medical Device License (MDL) application for all classes of devices, ensuring it meets Health Canada’s standards.

MDSAP and ISO 13485 Compliance

We support your quality management system to comply with MDSAP requirements.

Post-Market Compliance

Our support continues after approval, helping with ongoing reporting and market obligations.

Don’t Wait to be Stopped by Regulatory Compliance, Avoid Delays and Speed Up Your Approval

Licensing delays can cost you valuable time, money, and market position. At Quality Smart Solutions, we anticipate potential problems and solve them before they slow you down. Our expertise ensures your application is submitted accurately and on time.

Get Started Today – Your Device Deserves to Be in the Market

Contact Quality Smart Solutions today for a free consultation. We’ll help you navigate Health Canada’s process, so you can get your product into the hands of patients who need it.

What We Offer: Comprehensive Regulatory Support

When you partner with us, you gain a team dedicated to your success:

Custom regulatory strategies

Expert compliance knowledge

End-to-end project management

Ongoing support even after approval

Global Leaders in Medical Device Licensing (MDL/MDEL)

Assisted by a team of former Health Canada regulatory officials, MDEL & MDL License Experts, quality assurance specialists, and industry professionals, we provide insights and strategies to navigate the complex journey of medical device compliance and fulfill Class 1,2,3, medical device requirements.

20+ Years Experience

130,000+ Services Completed

100% success rate with MDL & MDEL

Former Government Officials

The Canadian Market Awaits – Don’t Let Licensing Slow You Down

Your innovation is ready for the Canadian healthcare market now. Let Quality Smart Solutions take the stress out of regulatory compliance, so you can focus on success.

Contact Us Today to begin your journey to Health Canada approval.

Quality Smart Solutions © 2021
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