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Medical Devices Regulatory Compliance

Demonstrate compliance, ensure safety and gain a competitive edge
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In the dynamic field of medical device manufacturing, partnering with a knowledgeable and reliable expert is crucial for addressing industry shifts, cost pressures and rigorous regulatory requirements. Regulatory compliance is more than a market prerequisite, it is a strategic advantage. Our services enable you to adapt effectively, showcasing your products' dependability and setting you apart in the competitive landscape.

Boost credibility and build customer trust

We enable you to:

  • Ensure product quality and consistency
  • Streamline production and service processes
  • Effectively manage risks with proven compliance strategies
  • Save time, money and resources
  • Expand market reach and access new opportunities
  • Stay ahead in the ever-evolving regulatory climate
  • Combat counterfeit products and enhance supply chain traceability
  • Elevate patient safety and treatment outcomes
Dedicated EU MDR and IVDR Information Center
Access important documents to guide your MDR and In Vitro Diagnostic Regulation (IVDR) certification applications in our information center.
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World-leading regulatory compliance services

As a world leader in assessment, auditing and certification, our global network of experts offers comprehensive support for regulations like the Medical Device Regulation (MDR 2017/745). With specialists worldwide, we ensure your compliance with diverse international standards. Our services, spanning EU MDR, CE marking, UKCA, ISO 13485 and MDSAP, are delivered by our EU Notified Body and UK Approved Body, ensuring robust, transparent assessments and a competitive edge through regulatory trust.

We are:

  • An EU medical device Notified Body (NB), with NB status in Belgium (NB 1639)
  • A UK Approved Body
  • An ISO 13485 (medical devices – quality management systems) Accreditation Body
  • A Medical Device Single Audit Program (MDSAP) Auditing Organization

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  • SGS Slovakia spol. s r.o.

Kysucká 14,

, 040 11,

Kosice,

Slovakia