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DirectoryRetail & CommerceWholesale - Health & Cosmetic ProductsBaselBAYOOCARE SWISS GmbH
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BAYOOCARE SWISS GmbH

Summary

About the company

The core activity of BAYOOCARE is to act as a Swiss Representative (CH-Rep) for foreign manufacturers of medical devices, supporting them in complying with Swiss regulations and communicating with the competent authority Swissmedic. This includes, in particular, taking over formal and safety-related concerns related to the placing of medical devices on the Swiss market.

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Industry:Wholesale - Health & Cosmetic Products
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Authorized Representative for Medical Devices
Authorized representative for medical devices in the EU, Switzerland and the UK; review of technical documentation, registration with authorities, communication with authorities, vigilance and market access.
International Authorisation of Medical Devices and IVD
International authorisation of medical devices and IVD; market analysis, authorisation strategy, regulatory research, technical documentation, submission to authorities and maintenance of registrations.
Strategic Consulting for Medical Devices
Strategic consulting for medical devices; product and market strategy, regulatory roadmap, evidence and study strategy, QMS and risk management integration, impact analyses.
Quality Management & Audits for Medical Devices
Quality management & audits for medical devices; setup and optimisation according to ISO 13485, internal audits, mock audits, supplier audits, support for external audits and integrated management systems.
Post-Market Services for Medical Devices and IVD
Post-market services for medical devices and IVD; PMS systems, PMS plans, PMSR and PSUR, PMCF and PMPF, vigilance, trend analyses and ongoing risk management.

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Location

Sandgrubenstrasse 44
4058 Basel

At a glance

Legal form
Limited Liability Company
UID
CHE-303.539.780
Founded
2022 · 4 years
Last commercial register change
August 4, 2022
Employees
11 to 20

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