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 manufacturing process validation risk assessment regulatory affairs technical dossiers clinical evaluation reports medical device development product registration auditing services consulting services validation services design control medical device certification support product lifecycle management other scientific and technical consulting services training and coaching iec 62304 qms implementation design history files iso 13485 regulatory consulting b2b medical device technical files biocompatibility software development biological safety biocompatibility testing medical device software development medical devices
Company Information
  • Employees 13
  • Founded 2008
Location

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

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