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GDPR Consultancy

The General Data Protection Regulation (GDPR) sets strict rules on how personal data must be collected, processed, and stored when concerning individuals located in the EU/EEA. For medical device manufacturers, this goes beyond basic data handling, it includes managing user feedback, clinical evaluations, and post-market surveillance. Obelis provides specialized GDPR consultancy helping you integrate data protection into every step of your compliance and quality processes.

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The Importance of Trademark Registration

for Brand Protection

Legal background

If your products are used by individuals located in the EU/EEA or if you process any related personal data, you shall comply with the GDPR. Failure to do so can result in hefty fines, reputational damage, and disrupted market access. With increasing digitalization and the integration of smart technologies in medical devices, data privacy has become an important matter.

Our GDPR support helps you:
  • Understand your legal responsibilities as a data controller or processor.
  • Establish lawful bases for collecting and using personal data.
  • Avoid penalties and strengthen your market reputation.
  • Align your data protection practices with MDR/IVDR requirements and your QMS.

Compliance isn’t just a legal requirement; it Is a key part of building trust with users and regulators alike.

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How to Achieve GDPR Compliance: Expert Consultancy for EU Data Protection Laws

Obelis offers tailored GDPR consultancy, ensuring your data processing activities comply with the European General Data Protection Regulation. With decades of regulatory expertise, we guide you in establishing lawful processing bases, aligning GDPR practices with your QMS, and keeping pace with regulatory updates. From identifying applicable data privacy laws to integrating GDPR into your compliance strategy, Obelis provides the knowledge and tools you need to protect personal data and maintain market access across Europe.

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Related Services

Compliance for Medical Devices in the European Union

Start your compliance journey with Obelis.