Regulatory Writing

Are you getting ready to release a new medical device? Does your technical documentation meet the requirements for CE-marking? Do you need support with clinical evaluations?

Medical Minds provides the medical and regulatory expertise to assist you throughout the entire product lifecycle: from the idea phase to product development, to CE-marking and post-market surveillance. We work in accordance with the Medical Device Directive (Council Directive 93/42/EEC), the relevant standards (e.g. ISO 14971 for risk management), and the most recent guidelines (e.g. MEDDEV 2.7.1 for clinical evaluations).

Our regulatory writing services include:

  • Clinical evaluation
    • Clinical evaluation reports (CERs) for medical devices class I / IIa / IIb / III
    • Post-market update of clinical evaluations
    • Regulatory pathway regarding clinical evaluation and post-market clinical follow-up (PMCF) study
    • Tailored training on clinical evaluation process
  • Technical documentation support
    • Clinical support for risk management: determination of harms, severity of harm and probability of occurrence, risk management report
    • Clinical support for functional and design requirements
    • Post-market surveillance (PMS)
    • Document review
  • Product labeling
    • Instructions for use
    • Surgical techniques
    • Patient information leaflets
  • Contract research activities
    • Study protocols