Over the past decade, in addition to helping its overseas clients enter the Chinese market, Qserve's China entity has consistently supported domestic Chinese companies in expanding abroad. Qserve is committed to providing quality, regulatory, and clinical consulting, auditing, and training services to manufacturers of medical devices and in vitro diagnostic devices.
Qserve has presented unique features compared to other domestic consulting companies over the years, our Business Development Manager Asia-Pacific, Minghua Chen will reflect these in this blog.
International Layout
Qserve, headquartered in the Netherlands, has taken into account the special market access requirements, language differences, and regional industry distribution across Europe, establishing branches in the UK, Germany, Belgium, France, and Italy. Beyond Europe, Qserve has also set up branches in the US and China's significant medical device consumption and supply markets. Qserve's business is not limited to the major markets of Europe, America, and China. Together with global partners, Qserve has extended its services to other countries in Asia, the Americas, the Middle East, and even Africa.
Qserve's global staff uses English as their working language. Still, the languages spoken by the staff cover over a dozen native languages, providing a solid foundation for customer service globalization, in-depth communication in detail, and interpreting regulatory and technical requirements, with comparison studies between countries. For example, in the early stages of the EU-MDR's publication, Qserve colleagues read the regulations in various official EU languages, quickly identifying certain discrepancies in translations that could impact the understanding and implementation of the regulations. They actively discussed and clarified these specific requirements with stakeholders, thus minimizing misunderstandings caused by differences in language translations.
Comprehensive Skillset
Countries have different national conditions and patient needs, leading to different development strategies and focused technology in the medical device industry. The complexity of medical device technology and its regulation requirements request reliance on professional teams rather than individual ‘supermen’. Building team capacity poses challenges for regulators, manufacturers, and consulting firms, but Qserve's global setup is highly conducive to meeting these challenges. Additionally, Qserve's flat matrix management structure allows every Subject Matter Expert (SME) to focus deeply on their area of interest while expanding their knowledge horizontally through collaboration with colleagues on diverse projects, forming a synergistic force to help clients face challenges.
- The professional experience of the Qserve team spans quality, regulatory, clinical, R&D, and management areas, which enables Qserve to provide comprehensive services to startups and offer extensive support for multinational, cross-departmental complex projects for large companies, not just limited to writing specific documents.
- Qserve team members not only have experience working in medical device companies but also in auditing and reviewing roles at notified bodies and regulatory agencies. Some experienced consultants are deeply involved in drafting regulations, guidance, and standards. In addition to medical device companies, notified bodies and other regulatory authorities are Qserve's clients. The qualifications of the Qserve technical team allow them to understand the challenges faced by regulators and the industry, providing technical support while also building better communication bridges between them.
- Qserve's team has extensive product experience covering active, non-active, active implants, in vitro diagnostics (IVD), software AI, and combinations products. This allows them to provide comprehensive and substantial support to a broader range of customers, especially those innovating new technologies.
Customization and Transparency of Services
- Coaching-style service: Unlike the operations of common domestic consulting companies, Qserve does not seek to monopolize a project; instead, it aims to establish deep cooperative partnerships with companies. Beyond helping companies smoothly obtain market access, Qserve hopes to leave a ‘spark’ and ‘base material’, cultivate a professional team, and establish a robust system within the company, allowing Qserve's exceptional professional resources to generate more excellent social benefits. Qserve's "I do-We do-You do" coaching-style customized cooperation model focuses on ‘teaching to fish’ rather than ‘giving a fish’, and its flexible time-based model also allows companies to adjust project scope and budget timely according to actual situations.
- Project manager service model: Regardless of the project size, Qserve assigns a project manager as the daily contact point. The project manager is the key consultant rather than a business person, making technical services more efficient. Additionally, globally recognized tools are used to share and co-edit work documents with clients, making the entire service communication process more transparent and reliable.
Long-Term Cooperation
Our partnership with clients often deepens with the growth of the companies.
- Interim Management during the initial startup stage: Startup teams often focus on R&D and sales and need professional personnel in quality, regulations, and clinical areas. Qserve team members can temporarily take on related duties during this stage and develop a subsequent handover plan;
- Early R&D stage: Quality and regulatory requirements should be important for design input. The project's feasibility study, market and regulatory strategy formulation, project implementation roadmap planning, assessment of overseas suppliers and sales chain partners, overseas clinical trial plans, etc., should all involve professional quality, regulatory, and clinical personnel. The Qserve team can share their valuable experiences and insights during this stage;
- Scale production stage: Qserve can provide more extensive services, such as awareness training or specialized training for the client itself and its supply chain, internal and external audits support, gap analysis, or remediation suggestions;
- Product registration stage: mock audits/reviews, quality system documents, and technical documentation drafting or guidance;
- PMS stage: assisting clients in planning and implementing proactive PMS, especially PMCF studies; when needed, also assisting enterprises in responding to authority inspections, vigilance and recalls, etc.;
- Overseas expansion stage: We can also participate in due diligence for mergers and acquisitions upon request, helping clients comprehensively assess the acquisition target company's global market access prospects, existing gaps, and the subsequent investments required. This is the key foundational information that needs to be clarified during the negotiation stage.
- Ad-hoc (also known as ‘Call-Your-Friend’) services of all stages: these include but are not limited to temporary consulting services, such as quick responses to some questions or assisting enterprises in coordinating communications with regulatory authorities/Notified Bodies and other third parties;
Today, Chinese medical device companies' service demands and overseas market strategies have significantly changed from ten years ago. Qserve has been thinking about how to increase the service for Chinese clients.
Chinese companies are more eager for but more cautious with overseas markets:
Facing domestic centralized procurement pressures and fierce competition, Chinese companies must go abroad to achieve good profit and reach a broader market. However, unlike the MDD era, when low-cost certification could easily support entering multiple markets, the MDR era has significantly increased certification costs and CE certification has clearer expectations for European clinical data. More and more companies realize this issue and no longer blindly 'have a go at it' but more cautiously select those products that are truly competitive in the European market for CE application; the access paths and compliance strategies for other markets are also adjusted accordingly. When helping companies formulate overseas market access strategies, Qserve will simultaneously consider the needs of all target markets, thinking globally rather than focusing on a single market or product.
Chinese companies take more active actions globally:
In the current environment of deglobalization, building multinational brands and multi-channel supply chains guarantees companies' sustainable and stable development. Activities such as overseas cooperation, investment, and mergers and acquisitions are more frequent. Qserve's international layout should match the needs of most companies, assisting in coordinating onsite visits and evaluating partners in various countries, assessing quality agreements, and monitoring their implementation.
Chinese companies are more aggressive in innovation:
With the total advancement of the ‘new quality productive forces’ and comprehensive policy support, more and more domestic companies' global business plans have shifted from OEM to high-quality innovation. In addition to leveraging its technical advantages to provide comprehensive support, Qserve should also fully utilize its international network to build more bridges for Chinese enterprises to go abroad and horizontally involve its partners to clear obstacles for innovative companies, such as overseas intellectual property protection, connecting with incubation, financing, clinical, scientific research, and other related platforms, reference to medical technology assessment (HTA), and medical insurance experts and other key links.
Chinese companies' talent training demand is more urgent:
Talent is the foundation for achieving all corporate goals; in response to the widespread and ongoing need for international talent training, Qserve will launch a new online training platform. Its modular and interactive architecture will make it easier for delegates to choose the appropriate time and content for their studies freely.
Additionally, Qserve will introduce an online platform embedded with AI technology for regulatory dynamics collection and dissemination, significantly saving the time enterprises spend on collecting and interpreting global regulatory intelligence.
Qserve is happy to listen to Chinese companies, understand their needs for global markets, and help them with various challenges. If you need support, please feel free to contact us.