Our Services

Product Development & Engineering

• Product design and development support from concept to prototype
• Design controls, documentation, and DHF (Design History File) creation
• Design for manufacturability and usability engineering
• Vendor and supplier qualification
• Technical file and design dossier preparation

Quality Systems & Regulatory Compliance

• Turnkey Quality Management System (QMS) development compliant with FDA 21 CFR 820 and ISO 13485
• Internal and supplier audits
• CAPA, complaint handling, and post-market surveillance systems
• Regulatory strategy and submission support (510(k), technical files, EU MDR transition)
• Audit readiness and inspection preparation

Risk Management

• ISO 14971–compliant risk management file creation
• FMEA (Design, Process, and Use) development
• Integration of risk-based decision making into design and quality systems

Project Management

• Cross-functional project leadership and milestone tracking
• Resource and cost optimization for startups
• Program dashboards and progress reporting
• Stage-gate or agile implementation tailored to company maturity

Validation & Verification

• Equipment, process, and software validations
• IQ/OQ/PQ documentation and execution
• Test protocol development and statistical data analysis
• Pharma validation expertise for combination products or pharma–device integrations

Information Technology Solutions

We combine our medtech experience with IT expertise to create digital systems that enable compliance and scalability.

• Electronic Quality Management Systems (eQMS) setup and integration
• Document control and electronic signature systems (21 CFR Part 11 compliant)
• Cybersecurity and data integrity solutions for connected medical devices
• Cloud-based infrastructure design for startups (secure and cost-efficient)
• ERP, MES, and validation for software and digital tools
• IT validation (CSV, software qualification, and documentation)

Commercialization & Business Readiness

• Regulatory and clinical strategy alignment
• Manufacturing transfer planning