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Good People Working on Good Projects with Good Process

Case Study 3: International oversight

Situation Large medical device firm needed assistance with world wide governmental approvals to introduce a new device to the market, support development of clinical evidence and risk documentation and to create world wide regulatory submission strategies and documents.
Frestedt Approach
  • Integrate with team to execute regulatory strategy
  • Worked with internal writing, engineering and international regulatory groups to train and develop CERs, risk management reports, manuals/IFUs, and regulatory submissions, etc.
  • Training provided for required regulatory submission components to meet international standard and regulatory requirements (e.g., council directive 90/385/EEC and ISO 14971, MEDDEV 2.7.1, Rev 4 and others)
Results Project is ongoing after over one year with multiple regulatory interactions. Training and development is impacting all departments associated with the project.

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