In today's globalized world, expanding your medical device business internationally requires a thorough understanding of regulatory requirements and market access procedures. To navigate these complex challenges successfully, partnering with a reliable and competent organization is essential. Enter DQS, your one-stop-shop global partner for conquering new markets and ensuring compliance. With its comprehensive suite of services and industry expertise, DQS acts as the passport to the world for your medical devices.

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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:

  1. MDD Monitoring Activities: DQS supports companies in replacing a previous notified body, ensuring a smooth transition and uninterrupted compliance.
  2. MDR Certifications: DQS assists in meeting the requirements of the Medical Device Regulation (MDR) for market access within the European Economic Zone.
  3. 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.
  4. 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.
  5. 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.

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Embrace the passport to the world that DQS offers and unlock new horizons for your medical device business.

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Author
Michael Bothe

Michael Bothe is Head of the Notified Body for Active Medical Devices and is also a lead auditor. He is also involved in standardization at the German Institute for Standardization (DIN) and the German Commission for Electrotechnical, Electronic & Information Technologies (DKE) and coordinates continuing education activities for customers. His interests include integrated audits as well as process optimization of conformity assessment procedures.

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