Projects

This page provides examples of areas of expertise and solutions we provide. If you are facing a challenge, Contact us with an enquiry; we will respond within 24 hours, arrange a conversation as needed, and provide a free assessment or proposal.

Product Planning, Launch and Compliance Support

• Regulatory strategy and positioning in front of European, US FDA, and other authorities.
• Special focus on Human Factors Engineering (planning, HFS studies), and Cybersecurity.
• Implementation of global complaint management, post-market surveillance, and vigilance reporting.
• Investigation of critical events and trends; resolution in collaboration with manufacturing and R&D.
• Clinical Evaluations, and Post-Market Surveillance Reports.
• Preparation and assistance to Certification Audits.

Due-Diligence and Technology Transfer

• Technical and regulatory assessment of medical device and software technologies.
• Assessment of Quality Management Systems; harmonization and certification of global processes.
• Design transfer planning, gap assessment, and management of technology transfer.
• Manufacturing transfer, revalidation, including audit and transfer of suppliers.

Quality System Implementation

• Implementation, extension, and cross-site harmonization of quality systems.
• Establish compliance with ISO 13485, IEC 62304, ISO 27001, CMDCAS, FDA Part 820 and Part 11.
• Implementing effective processes for Medical Device Software, while meeting regulatory (FDA) requirements.
• Business process reengineering, implementation of automation, and validation of software solutions.

C++ Software Engineering and Validation

• C++ mentoring, architecture design; development planning, and optimization of methodologies.
• C++ best practices for efficiency and safety; Security and code safety reviews.
• Modular architecture, refactoring, speeding up development
• Multi-threaded integration of optical tracking; embedded systems, drivers; motion control.
• Process and documentation compliance with ISO/IEC 62304, MDD, and FDA requirements.

Vision-guided automated manufacturing

• Accurate drug deposition on microstructures of an implantable device.
• Automatic feature detection, overcoming part distortions caused by prior manufacturing steps.
• Functional proof of concept and prototype device delivered within 4 month of mandate approval.
• Equipment deployment, software and manufacturing line validation in Asia and the USA.