China's Best One-Stop Medical Equipment Provider
About

MDProject, also known as Medical Device Project B.V., is an independent consultancy based in Alphen aan den Rijn, Netherlands. The company specializes in quality assurance and regulatory affairs for the medical device industry. Their mission is to provide expert consultancy services that focus on regulatory compliance, quality management systems, auditing, training, and technical file support for medical device manufacturers and health institutions. The core services offered by MDProject include quality and regulatory consultancy, project management, technical documentation support, quality management system implementation, and training. Their team consists of professionals with strong technical backgrounds in biomedical and medical engineering, ensuring practical industry experience in product development and regulatory submissions. MDProject serves a diverse range of clients, from startups to established companies, helping them navigate complex regulatory landscapes and achieve market approval efficiently. The company is certified under ISO 13485:2016, reflecting its commitment to quality and regulatory excellence.

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Keywords
medical equipment manufacturingprocess validationrisk assessmentregulatory affairstechnical dossiersclinical evaluation reportsmedical device developmentproduct registrationauditing servicesconsultingservicesvalidation servicesdesign controlmedical device certification supportproduct lifecycle managementother scientific and technical consulting servicestraining and coachingiec 62304qms implementationdesign history filesiso 13485regulatory consultingb2bmedical device technical filesbiocompatibilitysoftware developmentbiological safetybiocompatibility testingmedical device software developmentmedical devices
Company Information
  • Employees13
  • Founded2008
Location

556 Lupinesingel, Alphen aan den Rijn, South Holland, Netherlands, 2403 EB

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