For biomaterials startups, the road from lab to market is filled with hurdles. One of the biggest? Building a Quality Management System (QMS) that meets ISO 13485 and applicable MDR requirements.
“It’s where many young companies struggle,” says Jessica Ossel, QA Manager at SBMC. “Founders are passionate about science and innovation, not quality management and documentation. But without a QMS, innovations simply won’t reach patients.”
From Roadblock to Accelerator
To remove this barrier, SBMC developed Quality Management as a Service (QMaaS). Instead of spending months or even years and many resources on creating a system from scratch, startups can plug directly into SBMC’s framework.
“We don’t just provide templates,” Jessica explains. “We guide companies step by step, adapting our proven system to their specific needs. That saves enormous time and resources—and gives them the confidence to face investors, regulators, and auditors.”
SBMC’s QMaaS offering includes:
- Ready-to-use QMS blueprints, covering documentation, design control, and equipment management
- Hands-on coaching to embed quality in daily operations
- Scalable compliance, ensuring systems evolve as companies grow
Credibility and Speed
By adopting QMS early with SBMC, startups gain more than compliance. They build credibility with stakeholders, avoid costly delays, and create a structure that scales from prototype to manufactured product.
Why SBMC?
SBMC combines expertise with infrastructure. Under Jessica’s leadership, SBMC achieved ISO 13485 certification for its own facilities allowing startups to develop and validate biomaterials while staying aligned with the highest quality standards.
“Quality should never be a roadblock,” Jessica says. “It should be an enabler. That’s what we deliver at SBMC.”
Interested in making quality your advantage?
For more information on SBMC’s Quality Management services – including rates:
