We combine deep regulatory knowledge with hands-on engineering experience. Because medical device consulting should solve problems, not just point them out.
Medical device companies need more than regulatory guidance. Our consulting team brings practical solutions from years of hands-on experience. We’ve guided hundreds of devices through development and market approval. This means we spot critical issues early and know how to fix them efficiently.
Your early decisions shape your entire timeline. Our engineering team goes beyond basic user needs to capture the full technical scope. We build test management solutions that improve current efficiency and reduce future update costs. This comprehensive approach prevents the cascade of rework that typically hits engineering departments late in development.
We create solutions that work for your business, not generic templates. Our approach integrates regulatory requirements with your existing processes, cutting development time and reducing overhead. We focus on automated solutions that support rapid growth without constant revision.
We help companies move beyond scattered files and folders. Our digital solutions span:
Medical device testing requires sophisticated facilities and deep technical knowledge. Our experienced engineers guide you through complex testing requirements and coordinate with leading test facilities. We support all critical areas:
Our consulting team includes quality system architects, medical device engineers, and project managers who have shepherded products from concept through market success. We understand both the technical challenges and business pressures you face.
While we handle complex tasks directly, we also excel at strengthening your team’s expertise. Through targeted training and guided implementation, we help your staff master quality processes and regulatory requirements. This gives you the flexibility to handle routine tasks internally while calling on our expertise for specialized needs.
Whether you need specific technical expertise or complete project support, we’ll help identify the right approach for your situation.
Project Management for Production Expansion.
Managed facility expansion via Gemba walks, document reviews, and equipment validation.
Outcome: Increased production capacity by 100% to meet growing market demand.
Strategic Component Development & Integration.
Led project management for critical component development and exchange
Outcome: Ensured seamless integration of new components, maintaining platform stability and meeting all project deadlines.
Intensive FDA Audit Preparation.
Deployed a full-scale audit readiness program including mock audits, validation reviews, and CAPA system reinforcement.
Value Delivered: Provided the robust, third-party validation and process hardening required to face FDA scrutiny with confidence.
Digitalization with Orcanos Platform.
Led automation and process optimization project.
Outcome: Reduced manual documentation effort by over 30% and streamlined the design control process.
Product Family Certificate Modernization.
Managed the complex project of updating IEC 60601-x series certificates for entire product families to the latest versions
Value Delivered: Demonstrated deep expertise in navigating evolving international standards, ensuring continued regulatory compliance and market access for the client’s core products.
End-to-End QA Support for New Platform Realization
Provided comprehensive support from requirements engineering to final QA testing for a new device platform.
Value Delivered: Acted as an integrated part of the client’s team, providing the specialized QA and validation expertise needed to bring a new technology platform to life.
Initial ISO 13485 Certification for a Digital Health Startup
Built their Quality Management System from the ground up.
Outcome: Achieved initial ISO 13485 certification on the first attempt, enabling market entry.
Embedded Product Development Support
Provided critical support for a new embedded software project.
Value Delivered: Our targeted intervention filled a critical knowledge gap in the client’s team, preventing project delays and ensuring a robust development process.
MDR Transition and ISO 13485 Certification Support
Assisted with audit preparation, CAPA resolution, and technical documentation remediation for the MDR.
Value Delivered: Provided the necessary expertise and manpower to strengthen the client’s QMS and technical files against the heightened requirements of the MDR.
Advanced Risk Management Support.
Focused on integrating Post-Market Surveillance (PMS) and PMCF data back into the product risk management files.
Value Delivered: Ensured the client’s risk management process was a true “living document,” actively updated with real-world data to improve product safety and compliance.
Comprehensive QM and MDR Transition Support.
Acted as an extension of the client’s QM team, assisting with audits, CAPA, process optimization, and MDR preparation.
Value Delivered: Provided flexible, high-level support across the entire quality system, helping a large organization meet its extensive regulatory and MDR transition goals.
Specialized Risk Management for Navigated Surgery
Focused on the management of critical performance attributes and supported the IEC 60601 certification process.
Value Delivered: Provided highly specialized risk management expertise for a complex, software-driven navigation system, ensuring safety and successful certification.