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Technical File Assistance

 

Writing the technical file


The technical file is the centre of your system to obtain the CE mark, it contains proof of your due diligence in meeting the requirements of the MDD or IVD. Cavendish Scott has helped many companies develop and implement both the CE mark and their technical file. We do this by helping you;

  • Prepare the Declaration of conformity
  • The Essential Requirements Checklist
  • Risk Analysis
  • Selection of Notified body
  • Create a vigilance systems
  • Lias with the European Representative


Links to the directives

CE Mark technical file - Management Representative

Our clients are our success

We started ISO 9000 on our own but found we were over designing the system. Cavendish Scott helped us focus on the fundementals of both the standard and our business.

GTS, Concord, NH

Our first mistake was not to use Cavendish Scott initially. Our first consultants did not understand our needs, they left us with pages and pages of worthless documents - we ended up throwing it out. Cavendish Scott were able to come in, design us a simple and effective solution and get us registered in just 3 months.

SalvageData, Stamford, CT

As a busy and profitable company, we wanted to ensure that we were keeping our quality system in shape and continuing to benefit from our systems. That's why we use Cavendish Scott to carry out our internal auditing. They remain objective, efficient and effective.

DTi, Southborough, MA