Quality Management System (QMS) Development

We build flexible, standards-aligned QMS solutions tailored to your stage and strategy. Borderless MedDev implements what you need, when you need it.

We ensure alignment with:

  • FDA QMSR (21 CFR Part 820)

  • ISO 13485

  • Regulatory requirements for medical devices and QMS

  • MDSAP and other international frameworks

Process Development

Training

Internal Audits

Supplier Audits

Technical Files​

Calibration Support

What We Do

Design Controls/ Design History Files

  • Wireless registrations and testing expertise

  • Cyber Security

  • Coexistence

  • Interoperability

  • Biocompatibility

  • Mechanical Testing​

  • Risk Management

  • Usability

  • Labelling

  • EMC

  • Safety

  • Software documentation

Accelerating Access to Innovation

Borderless MedDev offers hands-on training to ensure your internal teams understand and meet FDA requirements. Our experts equip your staff with the knowledge and tools they need to keep your system running smoothly and your entire organization aligned.

We act as your partner, coach, and sounding board, ready to support you at every turn.

Services Include:

  • QMS design, implementation, and documentation

  • Gap assessments and remediation

  • Internal audits and mock inspections

  • Ongoing quality system maintenance

  • Fractional quality management support

  • Training for FDA QMSR, ISO 13485, ISO 9001, ISO 15189

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Flexible Solutions Made for You

The regulatory landscape is complex, filled with strict requirements and details that can delay patient access to cutting-edge technologies. Without a full-time regulatory staff, it’s easy to feel overwhelmed. Borderless MedDev can step in as fractional regulatory and quality leaders to fill the gaps.

This flexible support model scales with your needs, giving your internal team the freedom to focus on innovation and product development.

Explore QMS Support Options