Our services for Medtech are comprehensive and compliant with regulatory requirements. Consultancy and collaboration in the following services.

 

Our services for medtech:

• Feasibility assessments and research for new medical products

• Developing business plans

• Development support (quality engineering)

• Establish technical documentation

• Carry out system risk analyses, design risk analyses and process risk analyses

• Carry out supplier evaluations and supplier audits

• Support in the approval of medical devices

• Collaboration in post market surveillance and vigilance cases

• Monitoring changes in laws, standards and guidelines​

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In providing our services, we implement the following legal and normative requirements of Medtech:

• ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes

• FDA 21 CFR part 820 Quality System Regulation

• Swiss Medical Devices Ordinance MepV 812.213

• European Medical Devices Regulation 2017/745 MDR

• FDA admission requirements

• Medical Device Single Audit Program MDSAP