Transforming Healthcare Through Technology

Our regulatory experts guide your product through every stage of the approval process. We have experience across all major FDA pathways and international submissions.
Capabilities include:

• 510(k), De Novo, PMA, and IDE submissions
• Q-Sub and pre-submission meetings with FDA
• Regulatory strategy and classification analysis
• Labeling, UDI, and IFU compliance
• Post-market surveillance and change management

We build and maintain compliant, efficient quality systems tailored to your organization. Our goal is to help you achieve and sustain regulatory readiness.
Capabilities include:

• ISO 13485 system implementation and training
• FDA 21 CFR Part 820 compliance
• Design control documentation and DHF management
• Risk management in line with ISO 14971
• Internal and supplier audits

We design, execute, and document test plans that confirm your product meets all design and performance requirements.
Capabilities include:

• Test plan and protocol development
• Mechanical, electrical, and software testing
• Data analysis and validation reports
• Traceability matrix documentation
• Environmental and reliability testing

We help ensure that your device materials and packaging meet biocompatibility and sterilization standards for safe clinical use.
Capabilities include:

• ISO 10993 biological evaluation planning
• Cytotoxicity, sensitization, and irritation testing coordination
• Sterilization validation (ISO 11135, 11137)
• Packaging integrity and shelf-life testing
• Biological risk assessment and documentation

We provide technical support from prototype production through commercial manufacturing, ensuring consistent product quality.
Capabilities include:

• Supplier qualification and audits
• IQ, OQ, and PQ validation protocols
• Equipment and process qualification
• Production documentation and DMR creation
• Process improvement and scale-up planning

We integrate risk analysis and mitigation throughout your product lifecycle to ensure safety and regulatory compliance.
Capabilities include:

• Risk management plans and reports per ISO 14971
• FMEA and fault tree analysis
• Design and process risk evaluation
• Risk-benefit analysis and mitigation strategies

We assist with clinical evaluation planning, preclinical testing, and coordination with review boards and regulatory bodies.
Capabilities include:

• Clinical evaluation reports (CERs) and protocols
• IRB and ethics submissions
• Preclinical study planning and execution
• Cadaveric and bench testing coordination
• Data analysis and technical summaries

We empower teams with the knowledge and systems needed to maintain long-term compliance and operational success.
Capabilities include:

• Regulatory and quality system training
• Audit preparation and mock inspections
• CAPA and complaint management improvement
• Ongoing consulting for process optimization