Strategic Consulting Team
Our senior advisory team brings decades of specialized expertise in global medical device compliance, spanning the full spectrum of device classifications. Our proven track record includes guiding hundreds of products to successful market entry in the US, EU, China, and key Asian markets.
We provide integrated strategic solutions that unify quality management, environmental sustainability, and material compliance within a single, powerful framework.
Partner with us to transform regulatory complexity into your competitive advantage, ensuring accelerated and sustainable global market success.
Cindy Ni is a senior global regulatory affairs and quality management expert with over 20 years of experience in the medical device industry. She specializes in delivering efficient compliance solutions for market access in the EU, USA, China, and other key Asian markets, covering the entire product lifecycle from pre-market registration to post-market surveillance.
Her core competencies include:
- Global market access strategy and product registration
- Quality Management System development and auditing
- Technical documentation and clinical evaluation
- Risk management and usability engineering
- Material compliance and data security requirements
- Team training
With extensive expertise in medical devices and IVDs, she has successfully led hundreds of global registration projects across all risk classes. She has built quality systems compliant with ISO 13485, MDSAP, and regulations in China and Korea for numerous multinational companies, and has successfully passed audits from authorities and notified bodies including those in the US and China.
As a contracted trainer for TÜV SÜD, she is committed to advancing professional knowledge in the industry. Choosing her as your partner means working with a trusted global compliance advisor who will guide your products to steady success in the international marketplace.
Jan Schweibold is a senior Quality and Environmental Management Systems expert with over a decade of experience in the medical device and manufacturing industries. He specializes in building integrated management systems compliant with ISO 13485, various national regulations, and ISO 14001 requirements, with deep expertise in quality auditing, supplier management, and sustainable development.
His core competencies include:
- Quality Management System development and optimization
- Environmental Management System integration and ESG implementation
- Global supplier quality management and auditing
- Material compliance and production process control
- Process improvement and lean manufacturing
With extensive experience conducting over 100 audits, he has consistently served as the key lead in successfully passing audits by regulatory authorities and notified bodies including those from the US and South Korea. He has led the integration of environmental management systems into quality processes and established global sustainability frameworks. As a member of the Fraunhofer Institute's "Global Environmental Compliance" Expert Forum, he remains at the forefront of environmental regulatory practices.
As a TÜV SÜD certified senior auditor and quality expert, he continuously drives corporate quality improvement and environmental performance. Choosing him as your partner means gaining a reliable advisor with substantial practical experience and strategic vision, providing solid support for your management system and global compliance needs.