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