QLE : Helping your
expansion to Europe and beyond

Get Compliant Fast:
Within 1 Week, QLE Can Become Your Authorized Representative

For your product to enter the EU market, by law you must designate an Authorised Representative.

In addition to product compliance, companies that sell goods or services in the EU must also appoint an EU Representative for data privacy compliance under GDPR. By partnering with QLE, you’ll meet the requirements of Article 27 of the GDPR (EU) Regulation 2016/679, ensuring your company’s data privacy obligations are fully covered.

At QLE, we will provide you with a Certificate of EU REP Designation, essential for presenting to your Notified Body and Competent Authority during audits and inspections.

We can officially represent you within one week, and be named on your packaging within 24 hours of receiving a signed agreement.

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  • We guide you through obtaining or maintaining your CE Mark under MDR 2017/745 and IVDR 2017/746. Our services can also support your compliance with the latest EU regulations, including the General Data Protection Regulation (GDPR) and the emerging EU Artificial Intelligence (AI) Act.

  • As your appointed EU Authorized Representative, QLE acts as your point of contact with regulatory authorities, ensuring your compliance documentation is complete and up-to-date.

  • We streamline the process of obtaining Certificates of Free Sales/Trade from the European Union, facilitating smoother entry into global markets.

  • QLE  offers ongoing support for post-market surveillance and vigilance activities, ensuring your products remain compliant throughout their lifecycle.

  • From ground-up development to ongoing maintenance, we build robust Quality Management Systems compliant with ISO 13485 and 21 CFR 820, tailored to your specific needs.

  • Our team assists with the planning, execution, and management of clinical investigations, ensuring compliance with EU regulations and successful data collection.

  • We provide expert services for appointing a Person Responsible for Regulatory Compliance (PRRC) and Management Representative, ensuring that your company maintains continuous compliance.

  • Leverage our expertise in applying for funding through Horizon Europe, the EU’s ambitious research and innovation program with a budget of €95.5 billion. We assist with application preparation and project management to maximize your chances of success.

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Why Choose QLE?

  • Decades of Experience: Unparalleled expertise in EU regulations.

  • Dedicated Compliance Team: Experts including lawyers, engineers, pharmacists, former FDA, EMA, and EU Competent Authority professionals.

  • Tailored Solutions: Customized, cost-effective services.

  • Strategic Location:  Situated across the street from the European Commission HQ, QLE is at the heart of EU regulatory activity. Our proximity allows us to stay actively involved in working groups, monitor upcoming regulatory changes, and help you anticipate and adapt to new requirements.

  • Proven Track Record: Successful guidance for numerous companies.

  • Agile and Responsive: Quick, adaptive strategies.

  • Comprehensive Support: End-to-end regulatory services.