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DirectoryBusiness & Technical ServicesManagement ConsultingSarnenSmartPath AG
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SmartPath AG

Summary

About the company

SmartPath AG provides consulting services for the medical technology sector, supporting the development, regulatory approval and lifecycle management of medical devices. Services include regulatory and clinical affairs, quality management and eQMS implementation, product development (biocompatibility, usability, risk management), Swiss Authorized Representative services and due diligence for investors.

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Technical Consulting & Engineering
✓ Offered6
Medtech Consulting
Consulting for medical devices across the entire lifecycle, from the investment phase and product development to market positioning; incl. development, manufacturing, regulatory compliance and project support.
Quality Management for Medical Devices
eQMS implementation and adaptation, internal audits, supplier qualification and supplier performance audits according to ISO 13485, FDA 21 CFR 820, MDR/IVDR and MDSAP.
Regulatory & Clinical Affairs
Regulatory and clinical strategy, risk classification, global approvals, technical documentation, labeling, UDI, PMS plans, CERs, PMCF and authority communication.
Medical Device Product Development
Project management from concept through market launch as well as biocompatibility, risk management and usability and human factors engineering according to ISO 10993, ISO 14971 and IEC 62366.
Due Diligence for Investors
Regulatory, clinical and technical due diligence for medtech investments, including assessment of QMS maturity, compliance, product readiness, risk profile, gap analysis and recommendations for action.
Swiss Authorized Representative (CH-Rep)
Swiss authorisation for medical devices with a CH-Rep agreement, document review, interface with Swissmedic, and support for PMS, vigilance and compliance updates.
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Location

Kägiswilerstrasse 17
6060 Sarnen

At a glance

Legal form
Corporation
UID
CHE-499.893.384
Founded
2021 · 5 years
Last commercial register change
February 10, 2025
Employees
1 to 10

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