This page provides examples of areas of expertise and solutions we provide.
If you are facing a challenge, Contact us
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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.