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DirectoryBusiness & Technical ServicesManagement ConsultingLiestalhealthcare projects consulting & management Stein
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healthcare projects consulting & management Stein

Summary

About the company

The company healthcare projects consulting & management Stein provides consulting and management services for medical technology companies, particularly in the areas of quality management, conformity assessment and registration of medical devices. The core activity of the company includes supporting companies in complying with regulatory requirements, implementing quality management systems and conducting conformity assessments for medical devices.

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Offering

Products & services

Industry:Management Consulting
✓ Offered8
Consulting and management for medical devices
Consulting and management for medical devices, from process analysis and objective definition and strategic direction through to implementation, as well as support for approval and compliance.
Medical device approval
Medical device approval in Europe according to EU MDR 2017/745 and other regulations, including support from initial consulting to complete takeover of the approval process.
Conformity assessment for medical devices
Support for conformity assessment in the EU, EEA and Switzerland, including technical documentation, involvement of a Notified Body and CE certificate preparation.
Quality management for medical devices
Quality management for medical devices according to EN ISO 13485, including process analysis, objective definition, strategic direction and implementation.
Risk management for medical devices
Risk management for medical devices according to EN ISO 14971, covering the life cycle from development to disposal, including risk definition, evaluation and reduction measures.
Clinical evaluations
Preparation of clinical evaluations according to EU MDR 2017/745 for medical devices.
EU representative for third countries
EU representative services for third-country manufacturers, including role, tasks and obligations in the medical device context.
Seminars and coaching
Seminars and coaching for teams on quality management, conformity assessment, approval of medical devices, risk management and clinical evaluations.
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Location

Grammetstrasse 14
4410 Liestal

At a glance

Legal form
Sole proprietorship
UID
CHE-200.166.015
Founded
2020 · 6 years
Last commercial register change
February 3, 2025
Employees
1 to 10

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