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DirectoryBusiness & Technical ServicesOther Service IndustriesLa Tour-De-PeilzMedalps Sàrl
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Medalps Sàrl

Summary

About the company

The company provides services in the field of authorization and conformity of medical devices. It supports companies in obtaining the CE mark for their medical devices and offers consulting and services in the areas of quality management, regulatory affairs, and clinical evaluation. The core activities include the creation of technical documentation, the performance of risk assessments, clinical evaluation, and post-market surveillance. The company also supports compliance with standards and regulations, such as ISO 13485 and EU Regulation 2017/745.

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Clinical Evaluation
Clinical evaluations for medical devices under Regulation (EU) 2017/745 (MDR), including clinical evidence assessment and Clinical Evaluation Reports (CERs).
Biological Evaluation
Biological evaluation of medical devices under the ISO 10993 series, from Biological Evaluation Plans (BEP) and toxicological risk assessments to Biological Evaluation Reports (BER).
Quality Management System
ISO 13485 quality management systems for medical device manufacturers, including establishment and maintenance of compliant and pragmatic QMS structures.
Risk Management
Risk management systems for medical devices aligned with EN ISO 14971 and the EU MDR, including development and maintenance of compliant risk files.
PRRC for CH-REP
PRRC services for Swiss market access, supporting medical device manufacturers with the requirements for the CH-REP role and regulatory compliance.

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Location

Route de Chailly 210
1814 La Tour-De-Peilz

At a glance

Legal form
Limited Liability Company
UID
CHE-398.907.511
Founded
2021 · 5 years
Last commercial register change
August 6, 2021
Employees
1 to 10

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