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Medical device quality & regulatory experts

What We Do

The medical devices market is growing exponentially throughout the world. Device manufacturers tend to shape medical spending by bringing new products to market through emergency authorizations, quickly repurposing manufacturing lines, and modifying or upgrading old devices. Eventually, the regulatory and quality consulting market received a pivotal position, driving product approval for the manufacturers. We understand the small-mid size philosophy and the work they need to accomplish with constrained resources. Medical startup goes through tremendous challenges with regulatory and quality issues. FDA clearance is the most challenging in terms of time, expense, and resources. Grassstone has committed to help startups and small to mid-sized firms to help regulatory and quality needs.

The Technical Stuff

Whether you're just starting out or looking to restructure we've got you covered. Our mantra is: analyze, identify, advise, execute. Our mission is to create relationships, not transactions. Our promise is that we'll be there, as questions or issues arise, every step of the way.

Our Expertise

We're a group of medical device quality and regulatory experts and strategists that thrive on sharing our experience and knowledge to help you make a success of your device approvals. Our expertise proves that clear communication and expert collaboration with regulatory bodies boost your bottom line of pre-market and postmarket device success. Our services include medical device pre-market notification (510k) and premarket approvals (PMA) processes, risk management consulting, establishing and maintaining quality management systems, help conducting pre-sub meetings with FDA or other appropriate regulatory bodies, providing feedback support, help in conducting stage I and Stage II audits, and achieving final approvals for device marketing.

Grassstone

Our Experience

After a decade-long experience in the industry, our consultants collectively decided to alter direction. Now, we share our passion by helping others. Our ramp up process is designed to empower your team and outfit them with the tools they need to succeed. Talk to us today about how we can support your growth, limit your turnover, and put you on a solid track to success and profit in the competitive global medical device approvals and launch.

Our Approach

Our service includes a comprehensive consult to help identify gaps and opportunities in your current medical device pre-market approval process, a comprehensive report that includes a project plan with timelines and milestones, a cost analysis, and a schedule. We also offer a suite of quality products that will help you get there quickly and smoothly. That’s how we ensure your success.

Why Us?

Business mentors in regulatory approvals are key—that’s why when it comes to client selection, we’re choosy. We want to give each of you the time and guidance you deserve to bring revolutionary devices to market. Whether you’re seeking a strategic alliance with the right partner or a special skillset or tool, call us today. Together we’ll create and refine your plan for success. We didn’t get there alone. And neither will you.

Contact Us

Better yet, see us in person!

We love our customers, so feel free to visit during normal business hours.

Grassstone

5123 W 98th St # 2062, Minneapolis, MN 55437

Phone: (646) 387-7119 Email: contact@grassstone.com

Hours

Mon	09:00 am – 05:00 pm
Tue	09:00 am – 05:00 pm
Wed	09:00 am – 05:00 pm
Thu	09:00 am – 05:00 pm
Fri	09:00 am – 05:00 pm
Sat	By Appointment
Sun	By Appointment

Medical device quality & regulatory experts

Medical device quality & regulatory experts

Contact Us

Drop us a line!

Better yet, see us in person!

Grassstone

Hours

Welcome

What We Do

The Technical Stuff

Our Expertise

Subscribe

Grassstone

Our Experience

Our Approach

Why Us?

Contact Us

Drop us a line!

Better yet, see us in person!

Grassstone

Hours

Medical device quality & regulatory experts

Medical device quality & regulatory experts

Contact Us

Drop us a line!

Better yet, see us in person!

Grassstone

Hours

Welcome

What We Do

The Technical Stuff

Our Expertise

Subscribe

Grassstone

Our Experience

Our Approach

Why Us?

Contact Us

Drop us a line!

Better yet, see us in person!

Grassstone

Hours

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