Minier Medical Device Consulting

Focused leader with over 20 years of global sales, marketing, product development, quality, regulatory, and clinical experience in the medical device industry. Minier Medical Device Consulting is a network of medical device consultants who have worked together since 2005. Our backgrounds include Quality Assurance, Regulatory Compliance, Clinical Re... search, Product Development, Project Management, Marketing, and Global Compliance. Our teams are built to suit your project and give you the results you need in an optimal timeframe. Much of our recent focus has been helping small device manufacturers meet recently issued EU Medical Device Regulation (MDR) and MEDDEV 2.7.1 Clinical Evaluation Reporting (CER) requirements as well as complying with the new ISO 13485: 2016 Quality Management System (QMS) standard. Regulatory Compliance is the appropriate application of regulatory requirements to a Quality Management System (QMS) and the operations of medical device company. Our knowledge of regulations and standards helps shape and maintain your system. We can also conduct a gap analysis when regulations and standards change and help your company adapt in the least painful manner. Marketing in Europe requires the gathering of documentation of the device family into a Technical File or Design Dossier, again depending on the risk and classification of the product. The higher level class products will require certification of both the device's Technical File and the proper application of your quality system to meet the Essential Requirements according to the Medical Device Directive. The certification of your Quality Management System and approval of your product for CE marking is done through a Notified Body (NB). The NB will conduct an audit of your QMS and, where appropriate, your Technical File or Design Dossier. Minier MDC has extensive experience in working with the major NB's and can guide you through the process. The NB will conduct annual audits, quality system recertification audits every three years, and now ...Read More