Reduce business risk, avoid surprises and save cost.
The European Medical Devices Directive, MDD 93/42/EEC, and the new Medical Device Regulation 2017/745, require the manufacturer to prepare technical documentation (Technical File or Design Dossier). The technical documentation shall provide necessary proof that your device fulfills the requirements.
The documentation shall be available for inspection by national authorities. The documentation may also be submitted to a Notified Body for review in connection with the conformity procedure or surveillance activities for CE-marking.
Our experts can hands-on guide you through the process of creating clear and compliant technical documentation, for all directives and regulations – MDD, MDR, IVDD, IVDR, AIMD.
We can also carry out a pre-assessment of your technical documentation before it is submitted to a Notified Body.
This saves effort, money and time to market.
We can offer you the following services:
Define the information needed, including risk assessment and clinical evidence
Review device/system description and verify EU classification rationale
Define a verification and validation strategy based on applicable standards for your device
Review labelling, Instructions for Use and other technical documentation
Compile the Clinical Evaluation or the Clinical Performance Evaluation
Review the Clinical Evaluation or the Clinical Performance Evaluation
Review all existing documentation in support of meeting the applicable Essential Requirements of the Directive(s), or General Safety and Performance Requirements of the regulation(s). Evaluate and identify gaps or deficiencies in your documentation.
Compile your technical documentation in a clear and concise manner
Review your technical documentation prior to authority visits or Notified Body submissions
Contact me for further information Nils-Åke Lindberg
Office +46 46 286 88 90 or send me an e-mail