RQMIS

How RQMIS Helped a Medical Device Startup Scale Globally

The Situation

A start-up medical device manufacturer needed to achieve:

There was just one problem: They had no internal Regulatory or Quality team to make any of it happen.

In other words, they needed to build a compliant organization while trying to bring a product to market—at the same time.

RQMIS stepped in as a fully outsourced Regulatory and Quality function, providing both strategy and execution.

Established remote Regulatory and Quality departments
Delivered ongoing consultancy at a fraction of the cost of building an internal team

Achieved FDA clearance
Secured ISO 13485 certification
Obtained MDSAP approval
Built a fully functional Regulatory and Quality infrastructure—without hiring an internal team

RQMIS stepped in as a fully outsourced Regulatory and Quality partner, delivering both high-level strategy and hands-on execution.

Refined and strengthened the existing FDA regulatory strategy
Expanded it to include Europe (EU MDR) and Health Canada
Guided the company toward a De Novo 510(k) pathway through direct FDA interaction

Result: Alignment with FDA expectations instead of guesswork.

Supported execution of a Phase 3 clinical study for Health Canada
Managed key aspects of regulatory submissions across regions4. Full Remote Regulatory & Quality Department

Smart move for a startup: expertise without overhead.

Designed and implemented a fully integrated QMS
Aligned with:
- 21 CFR Part 820 (FDA QSR)
- ISO 13485
- MDSAP requirements

This wasn’t just consulting—it was building a company’s regulatory backbone from zero.

Instead of:

…the company got:

Need medical device consultancy service for FDA clearance?