China's Best One-Stop Medical Equipment Provider
About

We are an internationally operating service provider – headquartered in Switzerland – comprising experts in tailored solutions within Regulatory Affairs and Medical Devices. We serve as an Authorised Representative and importer in Switzerland, the United Kingdom, and the European Union. Furthermore, we provide audit services according to information security management systems (ISMS) ISO 27001 and medical device quality management systems ISO 13485. Our consulting services encompass medical device compliance within the comprehensive product life cycle. Our goal: Accompanying medical device manufacturers – from idea to successful market launch. Our vision: Safety through digitalisation. Today, we help companies to further expand their innovative edge and staying up to date.

Technologies
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Keywords
technical documentationlife science consultingehealthinformation security management system iso 27001eu medical device regulationauditingeu in vitro diagnostic medical device regulationmedical device softwarequality management system iso 13485data privacyregulatory change managementimport servicesconformity assessmentgxp complianceregulatory intelligence platformnist cybersecurity frameworkproduct lifecycle managementmedical devicesdata securitydigitalisation in medtechiso 19011gmp part 11ivdr eu 2017/746ai-powered complianceconsultingmanagement system implementationinformation securitycybersecurityhealthcare technologyproduct registration
Company Information
  • Employees5
  • Founded2020
Location

8 Grafenauweg, Zug, Canton of Zug, Switzerland, 6300

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