Quality as a Service for a Medical Device Startup

A newly funded medical device startup had successfully proven its technology concept but lacked the internal resources to navigate the complexities of Quality Management, Regulatory Affairs, and Technical Documentation. Building a robust Quality Management System (QMS) from scratch would have diverted precious time and funding from core product development. Instead, the company chose Zamann Pharma Support’s “Quality as a Service” model, which allowed them to join Zamann’s existing QMS framework within two months.

Through this approach, the startup leveraged Zamann’s MDR-compliant procedures, established infrastructure, and regulatory expertise. Costs were far lower than assembling an entire QMS independently, and the startup also shortened its product registration timelines significantly. The successful launch has led the company to maintain a close collaboration with Zamann, outsourcing the bulk of their QA and regulatory obligations to take advantage of the ongoing benefits of this unique partnership.

Challenges Faced

Limited Experience in QA and Regulatory: Thestartup had strong engineering and product capabilities but was unfamiliar with detailed compliance standards for medical devices.
Time and Cost Constraints: Venture capital funding came with tight deadlines, making a traditional QMS buildout risky due to high costs and long lead times.
Regulatory Pathway Uncertainty: While the startup had proven its product concept, they were still uncertain about the best path for regulatory approval and ongoing compliance.

Zamann Pharma Support’s Approach

Integration into Established QMS: Rather than starting from zero, the startup joined Zamann’s established QMS, saving considerable time and money. They immediately gained access to mature processes, SOPs, templates, and documentation structures aligned with regulatory norms.
Customized Regulatory Roadmap: Zamann mapped out a clear plan for MDR compliance, identifying the fastest paths to registration while ensuring thorough readiness for inspections.
Ongoing Consultant Support: The startup collaborated with Zamann consultants whenever they needed assistance. Whether it involved updating documents or addressing regulatory queries, the team had direct access to specialists at each step.
Infrastructure and Oversight: The infrastructure included software tools, documentation libraries, and communication channels that supported an efficient product registration process. This model also allowed the startup’s team to concentrate on R&D.

Results Achieved

Rapid Implementation: Quality integration took only two months, a fraction of the time normally required for a traditional in-house QMS build.
Lower Overall Costs: By using Zamann’s established processes, the startup avoided expenses associated with recruiting and training specialized QA and regulatory personnel.
Accelerated Product Registration: The startup leveraged Zamann’s compliant pipeline to bring their device to market sooner than anticipated.
Long-Term Partnership: With quality and regulatory matters largely handled by Zamann, the startup can focus on innovation and market expansion without neglecting compliance.

Client Testimonial

“Zamann Pharma Support’s ‘Quality as a Service’ model changed the game for our startup. We were able to integrate into their QMS swiftly, saving both time and money. The direct access to consultants and the MDR-ready pipeline helped us bring our product to market faster, and we continue to rely on Zamann’s expertise for ongoing QA and regulatory needs.”

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