«Nothing is more powerful than an idea at the right time.»
Victor Hugo
MEDTECH INNOVATION
SUPPORT FROM PRODUCT DEVELOPMENT TO PRODUCT APPROVAL AND MAINTENANCE OF TECHNICAL DOCUMENTATION FOR MEDICAL DEVICES
Our services for Medtech are comprehensive and compliant with regulatory requirements.
Our services for medtech:
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Feasibility assessments and research for new medical products
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Developing business plans
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Development support (quality engineering)
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Establish technical documentation
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Carry out system risk analyses, design risk analyses and process risk analyses
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Carry out supplier evaluations and supplier audits
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Support in the approval of medical devices
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Collaboration in post market surveillance and vigilance cases
In providing our services, we follow the following legal and normative requirements of Medtech:
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ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes
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FDA 21 CFR part 820 Quality System Regulation
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Swiss Medical Devices Ordinance MepV 812.213
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European Medical Devices Regulation 2017/745 MDR
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FDA admission requirements
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Medical Device Single Audit Program MDSAP