Medical Device Project Management

Project Management plays a central role for the product devel-opment of a Medical Device, IVD or Combination Product. We have extensive experience in leading the quality and regulatory work, and can support you in building and managing the team needed.

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Project Management usually starts with the categorization of the product to be a Medical Device, IVD or Combination Product. Project Management then moves into understanding the product maturity, to identify concept proof and the start of formal product documentation.

During the product development and risk assessment work, any additional expertise needs to be identified to be part of the team, such as biocompatibility, chemical categorizations, design verifications, usability evaluations, clinical evidence, etc. SDS MedteQ consultants hold experience in areas needed, so the project team easily can ask for detailed expert advice or additional resources when needed. Additionally, SDS MedteQ has a wide-ranging network of experts within other specific areas, and thus can involve or recommend other expert resources if needed.

The Project Management role most often ends with the design transfer and the implementation of continuous quality control of product manufacturing and product care. 

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