SERVICES AVAILABLE • CLINICAL DOCUMENTATION Clinical Evaluation, Post-Market Clinical Follow-Up, Post-Market Surveillance, Periodic Safety Update Reports, Biocompatibility Assessment Reports. • RISK MANAGEMENT Risk Management documents in compliance with ISO 14971:2019 • STUDY DESIGN Development of study design and study protocol for clinical investigations of medical devices • LITERATURE REVIEW Screening and review of scientific literature to support clinical evaluation, study protocols and research projects. ARETE-ZOE assists manufacturers in preparing technical documentation for submission to EU notified bodies and national regulatory authorities to certify their medical devices in compliance with Medical Devices Regulation (EU) 2017/745. Our team has an exceptional record in preparing documentation that successfully passes the certification process. Additional services include notification and follow-up with national competent authorities and notified bodies. We coordinate strategy closely with manufacturers for optimal results. We review, revise, and complete preparation of all parts of technical documentation required for successful certification of medical devices in the European Union. We produce internal training materials and processes to facilitate the transition to in house follow-up and maintenance. Our Team has an exceptional record of successful submissions. https://www.aretezoe.com/medical-devices

1. • CLINICAL DOCUMENTATION
Clinical Evaluation, Post-Market Clinical
Follow-Up, Post-Market Surveillance,
Periodic Safety Update Reports,
Biocompatibility Assessment Reports.
• RISK MANAGEMENT
Risk Management documents in
compliance with ISO 14971:2019
• STUDY DESIGN
Development of study design and study
protocol for clinical investigations of
medical devices
• LITERATURE REVIEW
Screening and review of scientific
literature to support clinical evaluation,
study protocols and research projects.
L E T U S H E L P Y O U T A K E Y O U R M E D I C A L
D E V I C E S T O T H E E U R O P E A N M A R K E T
ARETE-ZOE assists manufacturers in
preparing technical documentation for
submission to EU notified bodies and
national regulatory authorities to certify
their medical devices in compliance with
Medical Devices Regulation (EU)
2017/745. Our team has an exceptional
record in preparing documentation that
successfully passes the certification
process. Additional services include
notification and follow-up with national
competent authorities and notified bodies.
.
We coordinate strategy closely with
manufacturers for optimal results. We
review, revise, and complete preparation
of all parts of technical documentation
required for successful certification of
medical devices in the European Union.
We produce internal training materials
and processes to facilitate the transition to
in house follow-up and maintenance. Our
Team has an exceptional record of
successful submissions.
WWW. ARETEZOE .COM
ARETE-ZOE, LLC
Registered address: 1334 E Chandler Blvd, Box 5A-19, Phoenix, AZ 85048, USA
Correspondence address: P.O. Box 88255, Steilacoom WA 98388, USA
Tel: +1-631-791-8129 | email: veronikav@arete-zoe.com
S E R V I C E S A V A I L A B L E
One-Stop-Shop for Placing Your Medical Devices on the European Market