Product Commercialization

We will help you understand the importance of product commercialization management and how to accelerate the commercialization process in a reasonable and compliant manner, reducing risks and ensuring successful market launch for sales.

Project Management

Medical device R&D project management has its unique characteristics.  We may apply agile development methodologies flexibly to project management, allowing the software system to mature rapidly while also meeting quality system requirements.

HR and Communication 

The three essential elements for project success are people, communication, and project management skills. We will help you enhance your personnel management capabilities and facilitate more effective internal and external communication.

Quality Management

We offer training programs based on GMP/ISO 13485 standards and assist you in establishing a comprehensive quality management system (QMS) quickly and cost-effectively. Additionally, we can help you confidently navigate external system assessments and audits.

Regulaotry Services

Early planning of the registration pathway is crucial, including the opportunity to apply for innovative registration. We provide guidance in preparing documentation for NMPA product registration, production license and medical device operation filing.

Clinical Trials

We can assist you in writing clinical evaluation reports and provide expert opinions to help you select the appropriate Contract Research Organization (CRO).

Cybersecurity Management

We provide training on network security management processes and offer guidance in drafting related network security documents. It is crucial to pay special attention to products that require EU MDR and US FDA approvals right from the beginning.

HFE and Usability 

Human factors engineering and usability are particularly important for validation and risk identification in the early stages of product development. We will provide relevant design guidance training and assist you in completing testing activities and writing research reports.

Risks Management

ISO 14971, medical device risk management, is implemented throughout various stages of the medical device lifecycle. We will provide relevant management training and guidance. Additionally, we offer tool training for FMEA as well.