IVD Simplicity Ltd Logo - medical devices

IVD Simplicity Ltd

medical devices
China's Best One-Stop Medical Equipment Provider
About

IVD Simplicity has a range of consulting and training services covering regulatory, quality, product development and innovation to support you from product concept to commercialisation and beyond. Whether you are a start-up or an established small company, we provide flexible and and customised solutions that are clear, no-nonsense and cost effective. Our services include: - Regulatory consultancy, including product classification and regulatory strategy under the UK MDR, EU IVDR and other global regulations. - Quality consultancy, including QMS implementation and maintenance. - QMS auditing and gap analysis. - Product design and development consultancy from initial concept to product commercialisation and post-market improvements. - Innovation input to new product concepts. - On-site group training covering regulatory, quality and product development requirements.

Technologies
Google Cloud HostingMobile Friendly
Keywords
medical equipment manufacturingtechnical documentation reviewpost-market vigilancecost-effective solutionsrisk management (iso 14971)post-market surveillanceproduct lifecycle managementivd industryproduct design and developmentinnovationproduct concept to marketglobal ivd regulationsregulatory gap analysisproduct classificationregulatory pathway planninggap analysismdsapglobal regulationseu ivdr complianceproduct classification uk mdrnotified body auditsconsultingother scientific and technical consulting servicesregulatory submissionsquality management systemsregulatory complianceb2biso 9001performance evaluation planningfeasibility assessment
Company Information
  • Employees2
Location

Manchester, England, United Kingdom

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