Empower Functional Capability

With increasing regulatory scrutiny on medical devices, it is crucial for medical device start-up companies to establish a quality management system (QMS) early on, based on the applicable standards and regulations for their products. Waiting until the late stages of development or before market entry to prepare for QMS establishment can lead to serious compliance issues. Additionally, it is essential to ensure alignment between the established QMS and the requirements set by applicable standards and regulations, which requires careful attention.

What we can do for you?

Provide training courses on key processes such as design control and risk management, as well as the overall QMS, to enhance awareness and capabilities in quality management.

Our consultants can collaborate with start-up companies on a short-term or long-term basis to strengthen compliance in the quality management process and help establish and maintain high-quality process management.

Assess the existing QMS of start-up companies, identify weaknesses and management gaps, and facilitate timely improvements to meet increasingly stringent regulatory requirements.

Maintaining and improving the QMS should be integrated throughout the entire product lifecycle and involve various functional departments. If you have any concerns or questions regarding the establishment and maintenance of a quality management system, please let us know. We are happy to share our expertise.

For a startup company, it is quite challenging to establish a complete quality management system in a low-cost and fast manner. This is a systematic project that involves various functional departments and requires continuous improvement.

What we can do for you？

Guiding the establishment of system processes based on the applicable standards and regulations for the startup company's products, customized according to the actual situation of the company.

Our consultants can assist the startup company in establishing and maintaining an effective quality management system through short-term or long-term collaboration.

Providing training on relevant quality management systems to help your employees quickly familiarize themselves with all the related processes and start implementing research and production activities according to the processes.

Our consultants have extensive experience in quality management systems. They have participated in and led projects where quality management systems were built from scratch. If you encounter difficulties in establishing a quality management system, please feel free to contact us. Our consultants will help you establish a quality management system in the shortest possible time and at the lowest cost, eliminating your compliance risks.

For a startup company, undergoing a rigorous quality system audit by regulatory authorities during the product registration process can have a significant impact on the project timeline. If any non-conformities are found during the audit, it can result in unfavorable consequences and require a substantial amount of effort for rectification. So, how can you adequately prepare for a quality system assessment?

What we can do for you？

Our consultants have years of experience leading audits and can provide simulation audit services. This helps medical device startup companies identify potential flaws in their quality systems in advance and offer improvement suggestions. This will enable your company to be well-prepared for the upcoming system assessment.

In the event that you identify areas for improvement (discovered findings, not non-conformities) during the system assessment, our consultants can assist you in continuous improvement efforts.

 Our consultants can also provide expertise in the audit process, helping your employees quickly gain knowledge on how to handle a system assessment and organize a successful audit meeting.

External quality system audits should be given sufficient attention and careful preparation by startup companies. Our consultants have extensive experience in both internal and external audits. We can help you make thorough preparations and provide simulated external audits to ensure a smooth audit process. If you have any questions in this regard, please don't hesitate to consult us. We would be more than happy to share our expertise with you.

For a startup company, it is crucial to determine the market entry plan for future products early on and to plan the registration pathway and strategy. This includes assessing opportunities for applying for innovative medical device registration, which can provide early intervention support and priority review opportunities from regulatory authorities. Additionally, companies need to be aware of and control the risks associated with the Product Registration Certificate Holder system, which brings benefits but also requires attention.

What we can do for you?

Based on the intended use of the product, we can classify it according to the National Medical Products Administration's classification catalog and provide the corresponding regulatory requirements.

Basing on our experience, we can provide the optimal product registration pathway, which serves as an important input for your company's commercialization planning.

We can provide training on relevant regulations that need to be met for market access based on your company's market entry plan. For example, if your product is intended for the European market, we can provide training on the EU MDR application process.

If a startup company has a forward-thinking and clear registration pathway early in the project, it can effectively plan the project timeline, allocate resources in advance to complete relevant research reports and testing reports, which are often essential documents for registration submission.

For a startup company, after completing prototype production, type testing, and clinical evaluation, you can proceed with submitting the documentation for product registration. When preparing the relevant application materials, it is important to carefully review them from the regulator's perspective. This will directly impact the smoothness of the formal review process, and addressing deficiencies usually requires a significant amount of time and resources.

我们能为你做什么？

Guidance in compiling the required documentation for NMPA product registration, assisting startup companies in efficiently and effectively preparing the submission materials.

Our consultants can review the key documents intended for submission and provide improvement suggestions.

We believe that with the assistance of our experienced consultant team, we can help you efficiently complete the preparations for NMPA registration and reduce the preparation time. If you have any questions, please feel free to contact us. We would be happy to share our expertise and help you with the final document submission.

For a startup company, it is necessary to establish a quality management system that complies with applicable regulations and standards. In many countries and regions, ISO 13485 certification is recognized by regulatory authorities. However, NMPA does not mandate ISO 13485 certification for medical device manufacturers. Instead, NMPA requires companies to have a quality management system that aligns with China's Medical Device Manufacturing Quality Management Practices (GMP). Nevertheless, ISO 13485 standard remains an excellent tool to help companies establish a quality management system that meets regulatory requirements. Whether you plan to establish a medical device GMP system only or intend to obtain ISO 13485 certification, we can provide support when applying for a production license.

What we can do for you?

Our consultants can assist you in preparing for the production license application process.

We can conduct simulated on-site audits of the quality management system to identify any issues before the formal regulatory audit and ensure timely corrective actions.

Our experienced consultant team can help you thoroughly prepare for and successfully navigate the audit process to obtain the production license. If you have any questions, please don't hesitate to consult with us. We would be happy to share our experience and knowledge.

If a startup company has obtained a production license and product registration certificate, it still needs to undergo medical device business filing to officially launch and sell its products.

What we can do for you?

Provide relevant training on the medical device business filing process, including the required documents, procedures, and important considerations.

Offer agency services to handle the application for medical device business filing license on your behalf.

With the assistance of our consultant team, we can help shorten the preparation and application time for you. If you have any questions, please feel free to contact us. We would be happy to share our experience and knowledge.

If a startup company's products need to be marketed and sold in the United States or the European Union, they would require preparing applications for the US FDA's 510(k) clearance and the EU's Medical Device Regulation (MDR). In the preparation process, it is important to familiarize oneself with the relevant regulations and plan ahead.

 

The Medical Device Single Audit Program (MDSAP) is an initiative launched by the International Medical Device Regulators Forum (IMDRF). It is based on ISO 13485 and combines the regulatory requirements of five participating countries: the United States, Canada, Brazil, Australia, and Japan. The MDSAP audit is conducted by recognized auditing organizations and aims to fulfill the regulatory requirements of multiple countries in a single audit. If a startup company's products are intended for sale in the aforementioned five countries, applying for an MDSAP certificate would be necessary. Having an ISO 13485 certificate would greatly assist in the MDSAP application process.

What we can do for you?

Our consultants can provide relevant training and guidance to help you understand the regulations and requirements of the US FDA and the European Union.

Prior to your MDSAP application, our consultants can provide training and guidance specifically tailored to the requirements of the MDSAP application.

Depending on your needs, we can act as a representative of your company to liaise with foreign regulatory agencies and coordinate the submission of the 510(k) and MDR applications.

Our experienced consultants can assist with the review of the documents required for submission, reducing the risk of rejection.

With the assistance of our experienced consultant team, you can shorten the timeline for preparing the necessary technical documentation and obtain the relevant approvals quickly through our global partnerships. If you have any questions, please feel free to consult us. We would be happy to share our experience and knowledge. 

Writing a clinical evaluation report requires highly specialized knowledge and consumes a significant amount of time. However, for some non-clinical medical devices, the clinical evaluation report is a crucial document for medical device registration and market approval. Medical regulatory authorities in various countries, such as the European Union, the U.S. FDA, and China's NMPA, require applicants to submit comprehensive and scientifically rational clinical evaluation reports to ensure product safety, efficacy, and quality.

What we can do for you?

Our professional consulting team will develop clinical evaluation plans that comply with regulatory requirements, ensuring that the evaluation process is compliant, scientific, and systematic.

Our experts can help you with writing the clinical evaluation report, providing detailed descriptions of evaluation methods, data analysis, conclusions, and more.

Assist in executing the clinical evaluation plan and gathering, analyzing, and interpreting clinical data as per regulations.

With our wealth of experience and expertise, you will be able to efficiently complete the medical device clinical evaluation, ensuring product safety and efficacy, and providing strong support for a smooth market approval process. If you have any questions or need consultation regarding clinical evaluation services, please feel free to contact us. We are delighted to share our experience and knowledge with you.

Clinical trials play a crucial role in the medical device industry. Even for start-up companies that have obtained production licenses and product registrations, conducting clinical trials remains an essential step to ensure the safety, efficacy, and quality of medical devices. Clinical trials not only provide the necessary basis for obtaining market approval and sales permits, but they are also a critical step in validating product performance and effectiveness. Through scientifically rigorous clinical trials, companies can gain comprehensive insights into product performance in real clinical settings, identify and address potential risks, and provide patients with safer and more effective treatment options, thereby enhancing the company's market competitiveness.

What we can do for you？

Early clinical input: Our experts can provide clinical insights in the early stages of your project, helping to clarify clinical requirements and conducting preliminary assessments of product performance and safety from a clinical perspective.

Research clinical guidance: For non-registration clinical trials, such as research-oriented studies, we can provide guidance to improve your management and organizational capabilities without the need for additional CRO companies.

Clinical trial support: As you prepare for clinical trials, we can provide relevant training to familiarize you with the clinical trial process. We can also assist in selecting CRO/SMO companies and act as the liaison and coordinator between you and third-party organizations to ensure that the trials are conducted in accordance with regulations and scientific principles.

With our extensive experience and professional knowledge, we can assist you efficiently throughout the medical device clinical trial process, providing strong support for the successful market approval and sales of your products. If you have any questions or need consultation regarding clinical trial services, please feel free to contact us. We are delighted to share our experience and knowledge with you.