Get the Medical Device Clearances and the Quality Systems You Need

Your Pragmatic Quality Assurance and Regulatory Affairs Experts

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Go Further with Vision28

With experience ranging from quality control and submission review to regulatory affairs and compliance, we can help. Whether you only need one or two of our overarching services or a more robust package, you'll find the service that best fits your organization.

Experienced

Experienced

Our entire team holds decades of valuable medical device consulting experience.

Efficient

Efficient

We provide exactly what you need to minimize expenditures and overhead. 

Timely

Timely

As dedicated experts, we ensure a quick turnaround for any project we take on.

Vision28 at a Glance

Vision28 is an association of expert consultants with decades of experience in establishing quality systems and attaining market clearance for medical device companies active in Canadian, the US, and European regulatory markets. Our team has experience developing and defending quality systems in companies whose sizes range from Fortune 100 worldwide companies to start-ups trying to get their first product approved by the FDA and other regulatory bodies across the world, spanning Asia, Europe, and the Americas.

We have developed QMSL, a LEAN Quality System suitable for companies in their start-up, growth, or expansion phases. We also offer cloud-based document control, ideal for multinational companies who wish to have the ability to view quality system documents from anywhere in the world.

Our associates range from ex-FDA 510(k) reviewers to seasoned quality and regulatory executives from Fortune 100 companies.

Experienced. Efficient. Timely
Professional Team

Get Our Free Guide to 510(k) Submissions

510(k) submission is a crucial part of taking your device to market. Learn about our operation plan, submission steps, and what to expect during this process.

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Expert Guidance For All of Your Quality and Approval Questions

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Professional, highly responsive, and incredibly dependable

"Vision28 is very professional, highly responsive, and incredibly dependable. Their range of experience enables them to quickly target pragmatic solutions to the ever changing regulatory environment. We consider them a trusted partner and a source of competitive advantage."

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Gary Montague
CEO & Founder HeartHero, Inc.