Services

Your One-Stop solution

QS Experts offers you all relevant representation mandates in Europe and the United States from a single source. As an experienced partner, we take on the role of EU Representative (EU-REP), Swiss Authorized Representative (CH-REP), UK Responsible Person (UKRP) as well as U.S. Agent in accordance with FDA requirements. This avoids unnecessary duplication and noticeably reduces your administrative and regulatory costs.

At the same time, you increase your compliance security, as all mandates are centrally coordinated and documented.
Trust in our in-depth experience in the regulatory environment and benefit from a holistic solution that is oriented towards the requirements of your products and markets.

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Authorized Representation

Efficient, secure and fully compliant

CH-REP

Swiss Authorized Representative

EU-REP

European Authorized Representative

UKRP

UK Responsible Person

US-AGENT

US Representative to comply by FDA

Local Registrations

Local Registrations

Regulatory IMPORTER

for Switzerland, Europe and UK

Free Sales Certificates

from Switzerland, UK and Netherland

PRRC

Person Responsible for Regulatory & Compliance

Your Partner for Regulatory Compliance

Well-founded, practical and internationally coordinated

QS Experts supports manufacturers and distributors of medical devices in complying with regulatory requirements along the entire product life cycle. Our services range from MDR & IVDR-compliant preparation and review of technical documentation to clinical evaluation and investigation to the successful certification and registration of your products.

We accompany you in the preparation of audits and inspections by authorities or notified bodies and provide you with practical advice on the implementation of regulatory requirements in Europe, Switzerland, Great Britain and the USA. We are also available to advise you on changes in the regulatory environment, such as the implementation of new guidelines, transitional regulations or market surveillance requirements. Thanks to our international orientation and experience in various product categories, we ensure a consistent and efficient compliance strategy. Our goal is to combine regulatory certainty with pragmatic solutions – so that you can focus on innovation and market success.

  • Technical File preparation for CE & FDA Application
  • Technical File Review
  • Clinical Evaluation & Investigation
  • Predicate Device Comparison
  • Risk Management consulting (ISO 14971)
  • Usability Engineering (IEC 62366)
  • Certification & Audit support
  • PMS / CAPA / MIR Handling

Simplify Healthcare Compliance with Trusted Consulting Experts

Ready to learn more about our services or schedule a consultation? Our team is ready to answer your questions and help you.