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QMSphere

  • Quality & Regulatory Consulting for MedTech and Pharma​​​​​​

    Helping life science companies stay compliant, audit-ready, and globally competitive — with expert support in quality systems, regulatory strategy, and sterilization validation.

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Auditing & Quality Management Systems

We help you build and maintain robust, inspection-ready QMS frameworks aligned with ISO 13485, MDSAP, and FDA requirements. Whether you need support preparing for an audit or optimizing your internal processes, we’re here to help.

  • Internal & supplier audits (Lead Auditor)
  • Audit preparation (FDA, Notified Body, MDSAP)
  • CAPA, change control, and deviation management
  • Process improvement & Lean implementation
  • Management review, KPIs, and QMS optimization

EU MDR & Global Regulatory Compliance

Ensure your product meets global standards from day one. We specialize in bridging EU and US regulatory landscapes, supporting your global strategy with deep expertise in MDR and country-specific requirements.

  • ​Technical documentation (EU MDR, 510(k), renewals)
  • Regulatory strategy and submissions
  • Risk management (ISO 14971), FMEAs
  • Design reviews and product lifecycle support
  • Market surveillance, FSCA, complaints handling

From EtO to gamma sterilization — we guide you through validation, documentation, and process optimization with deep technical knowledge and hands-on experience.

  • Process validation: EtO, gamma, e-beam
  • Cleaning validations, lab equipment qualification
  • Validation Master Plan, protocol & report writing (URS / IQ / OQ / PQ)
  • Data-driven process improvement
  • CSV support & TrackWise validation

Sterilization & Validation

At QMSphere, we empower organizations to achieve excellence through expert quality management and continuous improvement. Specializing in comprehensive auditing, european regulations and sterilization processes, we uncover compliance gaps, drive operational efficiency, and implement targeted strategies that elevate performance. Let us help you build a resilient quality system that meets regulatory standards and propels sustainable growth.

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