FDA Medical Device and Drug Establishment Renewal by December 31, 2021
Compliance. Simplified.
Join More Than 900 Global Clients Who Trust Quality Smart Solutions As Their Comprehensive Compliance Partner.
Connect with our Experts
Leaders in Natural Health Product Compliance Solutions since 2007
Quality Smart Solutions has registered over 6,000 Natural Health Products (NHPs) serving over 900 clients since 2007 with a stellar success record. We have emerged as a global leader consulting firm in Health Canada and FDA compliance solutions.
Book 30 Min Free Consultation
Medical Device Licensing Experts for Canada & USA
Quality Smart Solutions offers medical device licensing and label compliance solutions for Class I, II, III, IV medical devices, software medical device (SaMD), medical device establishment license and renewals.
Book 30 Mins Free Consultation
Previous
Next

Proven Expertise

Proof in
Numbers

0 +

Years Experience

0 +

Clients Served

0 +

Services Completed

Why Quality Smart Solutions?

We take a personal approach to every client’s needs and goals. Our mission is to see your business thrive through compliance and risk mitigation. With a team of former FDA and Health Canada regulatory agency officials, regulatory experts, quality assurance specialists and  industry professionals we  provide insights and strategies to navigate the complex journey of regulations to help you make clear, decisive decisions to grow your business.

Serving You First

Your business and compliance needs are our priority. By first educating you about the regulatory requirements, then outlining how our solutions complement your strategy, our best-in-class approach helps your business grow.

Decades of Experience

Our team, consisting of former government agents to industry professionals, our knowledge and situations will guide your business in the right direction, ensure you complay and mitigate risk.

Import Solutions

Our sister company, Quality IMPORT Solutions, holds a Health Canada licence to import Natural Health Products and a CFIA license to import conventional and supplemented foods.

We Help You Grow Globally

We support your domestic and international growth by offering regulatory solutions both in-house and with our extensive international compliance network partners so you comply with the applicable jurisdiction's regulations.

Available to Serve You in Canada and USA

We serve global clients from our North American headquarters by offering trusted compliance services.

CANADA
USA

Testimonials

Edward Ro Amazing Grass

“We’ve worked with Andrew and the QSS team for 5 years and they’ve always been very knowledgeable and professional. They’re a tremendous partner to have when dealing with Health Canada compliance regulations and will always work with you to come up with the best solutions.”

Michael T MT Consulting

I have been working with Andrew and his team at QSS for a couple of years now. I have clients from many different parts of the world and each situation requires expertise and focus, which I’m getting from QSS. I highly recommend Andrew and QSS to any perspective client who wants to “get it right” regarding Canadian and cross border compliance.

Don Gauvreau Pharma Freak

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!

Brands We Serve

Articles from Us

Follow Latest News, Blogs & Industry Updates
News

FDA Issues Sodium Reduction Final Guidance

On October 13, 2021, the U.S. Food and Drug Administration (FDA) issued final guidance for the food industry that provides voluntary, short-term (2.5 year) sodium

... Read more
Medical Device
Blog

Medical Device License (MDL) Renewals

As a Canadian medical device license (MDL) holder, you are subject to an annual license renewal procedure. The renewal process has two purposes, the first

... Read more
Seeking Regulatory Help?

Please complete the form below. We will respond to you within 1 business day.

Select all applicable Services
Select countries of interest
This website uses cookies to provide necessary site functionality and improve your online experience. By using this website, you agree to the use of cookies as outlined in Quality Smart Solutions's online privacy statement.