Medical Device Regulatory Compliance

Regulatory-Approval focused Development from Day One

Our team applies a rigorous approach to every step of development to ensure your device is built in full alignment with regulatory standards from the start. From FDA QSR to ISO 13485, we keep compliance at the core of the development process to ensure we avoid regulatory mishaps.

Why It Matters

Aligning with regulatory standards throughout development reduces the risk of delays, rework, and submission rejection. It is critical to build this core measurement throughout the entire development process from the start. 

H2: Our Approach

Our deep regulatory expertise ensures you build a strong foundation and develop traceable, auditable documentation throughout the lifecycle of your device.

Our Regulatory Compliance Services Include:

• Guidance on Medical Device Standards

• FDA Quality System Regulation (QSR) – 21 CFR Part 820

• ISO 13485:2016 Quality Management System Implementation

• Compliance Audits and Gap Assessments

• Integration of Regulatory Controls into Development Process

• Post-Market Surveillance

What You Get

A streamlined, compliant product development process that aligns with global regulatory requirements that is backed by documentation supporting inspections, audits, and submissions.