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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.
Authorized Representation
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