グローバル化が進む今日、医療機器ビジネスを国際的に展開するためには、規制要件や市場参入手続きを十分に理解することが必要です。このような複雑な課題を解決するためには、信頼できる有能な組織との提携が欠かせません。DQSは、新しい市場を開拓し、コンプライアンスを確保するためのワンストップショップのグローバルパートナーです。DQSは、包括的なサービスと業界の専門知識により、お客様の医療機器にとって世界へのパスポートのような役割を果たします。
Meeting Regulatory Requirements
To sell medical devices in the European Economic Zone, compliance with Directive 93/42/EU and Regulation (EU) 2017/745 MDR is mandatory. DQS assists companies in achieving and maintaining conformity with these regulations. Moreover, DQS can issue additional free trade certificates for several third countries, making it easier for your products to gain entry into those markets.
Support Across the Value Chain
DQS understands that expanding internationally involves more than just sales. The organization serves as a reliable partner throughout your entire value chain, whether establishing new production sites or collaborating with suppliers and service providers abroad. By ensuring compliance at every step, DQS enables smooth operations and minimizes risks.
Maximizing Efficiency
With DQS, the more "visa stamps" your passport has, the greater the possibilities for cost efficiency and redundancy reduction in conformity assessments. DQS achieves this through combined procedures, remote assessments, and the utilization of local experts. By streamlining the process, DQS helps you save time and resources while maintaining regulatory compliance.
DQS Service Offerings:
- MDD Monitoring Activities: DQS supports companies in replacing a previous notified body, ensuring a smooth transition and uninterrupted compliance.
- MDR Certifications: DQS assists in meeting the requirements of the Medical Device Regulation (MDR) for market access within the European Economic Zone.
- MDSAP (Medical Device Single Audit Program): By undergoing a single audit, DQS enables compliance with regulatory requirements in Canada, the USA, Australia, Brazil, and Japan.
- TCP III (Taiwan Technical Cooperation Program): European companies can enter the Taiwanese market without the need for additional audits by a conformity assessment body recognized by the TFDA.
- UKCA (UK Conformity Assessed): Post-Brexit, medical devices intended for the UK market must meet UK conformity requirements. DQS helps businesses navigate this regulatory landscape.
The DQS Advantage
By partnering with DQS, you gain access to an array of benefits, including:
- Expansion opportunities on both the sales and production sides of your business.
- Expertise from DQS assessors who possess deep industry knowledge.
- Tailored conformity assessment procedures that suit your organization's specific needs.
- A globally recognized passport with the necessary entry endorsements, ensuring acceptance worldwide.
Conclusion
In the ever-changing landscape of global medical device markets, DQS stands out as the ultimate partner, providing a comprehensive suite of services that facilitate compliance and market access. From regulatory certifications to value chain support, DQS enables you to expand your portfolio and thrive in the international marketplace. Embrace the passport to the world that DQS offers and unlock new horizons for your medical device business.
Get in touch!
Embrace the passport to the world that DQS offers and unlock new horizons for your medical device business.
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著者名
マイケル ボーテ
Michael Botheは、Active Devicesのの責任者であり、主任審査員も務めています。また、DINおよびDKEで標準化に携わり、顧客向けの継続教育活動もコーディネートしています。統合審査、適合性評価手順のプロセス最適化などに関心を持つ。
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