Health technology: medical devices
Are you puzzled by the new MD and IVD regulations on medical devices? Are you lost in the jungle of different authorities and health technology-related requirements? We know what needs to be done and when to place your products on the market.
Our team will find fast and the most suitable routes for your company in different phases of the life cycle of your medical devices (MD or IVD devices). We can give comprehensive guidance to lead you through the regulatory jungle concerning classification, identification of requirements, documentation, quality-related issues and regulatory affairs.
We are highly experienced experts in health technology, for example in the following areas:
- CE marked medical devices
- Various classifications (e.g. medicinal product/medical device) and regulatory processes as well as drug-device combinations (DDCs)
- Technical documents (writing, evaluation, e.g. transfer to production, qualification, validation)
- Risk assessment, clinical evaluation
- Device-related translations, e.g. promotional materials, instructions for use
- Co-operation with the regulatory authorities, e.g. consultation with notified bodies
- Health-economic reports
- Adverse incident systems and reporting
- Market surveillance and reporting (Medical Device Vigilance)
- Product complaints and quality systems
- Regulatory Compliance Officer services
- Databases (EUDAMED, UDI)
- Promotional material compliance.
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