Our mission is to help our partners achieve compliance in the medical device industry. We support our partners in placing compliant medical devices on the market, assisting them throughout the design and development process, as well as monitoring the devices once they are on the market.

We aim to understand our partner's needs and current status, ensuring that the most efficient service is provided.

We help place compliant medical devices on the market, managing and supporting both pre- and post-market phases. Our services include:

• Regulatory strategy development
• CE submission - MDR conformity assessment support (CE mark) with a comprehensive technical file
• FDA clearance (510k)

From literature research to clinical studies with direct physician and clinical access, we assist our partners in the followings:

• Clinical evaluation strategy and planning
• Clinical study execution
• Medical advisory services
• Direct clinical access

We offer expert advice and provide a fast path to a highly efficient Quality Management System, tailored to our partner's goals and ensuring the system is audit-ready. Our services include:

• QMS strategy and setup
• ISO 13485:2016, MDR, and FDA compliance
• Audits (internal, supplier, and management reviews)
• Notified Body selection and contracting
• Training programs

We advise our partners throughout their design and development objectives to ensure compliance with medical device requirements from concept to market, covering areas such as

• Concept feasibility
• Design Control
• Qualification and validation
• Risk Management

To determine the biological risk of a medical device, a thorough biological evaluation is required, including aspects such as:

• Biological evaluation strategy and plan
• Biocompatibility study - selecting and monitoring laboratory
• Biological evaluation summary and report
• Sterilization

We provide reliable software solutions for medical devices, while conducting comprehensive cybersecurity risk assessments to ensure secure and compliant performance:

• Software development and testing
• Software validation
• Risk assessment
• Validation

We support our partners in placing compliant medical devices on the EU and U.S. markets by assisting with the followings:

• Registration procedure
• Technical Documentation compilation in accordance with MDR requirements
• Preparation of FDA compliant (510k) documentation
• Submission and certification procedure
• Authority and Notified Body contact

It will be available from 2025 and will include the following offerings:

• Preparation of Post-Market Surveillance Plan
• Periodic safety update report
• Post-Market clinical follow up
• PRRC service