Comprehensive services in development and certification of medical devices
We offer comprehensive services concerning medical devices, including classification of customer products, development and compilation of technical file according to requirements of MDR Regulation (2017/745), and certifying them with the involvement of the Notified Body.
We assess medical devices in terms of their composition, administration route, dosage and application. Based on legal requirements, we classify medical devices as appropriate. If the MD classification criteria are not met, we give sugesstion to modify medical device composition or changes to the category of the medical devices concerned.
We design and develop medical devices along with technical documentation which includes medical device clinical assessments and risk analyses. We provide extensive assistance in registering the MD in keeping with applicable requirements (Regulation (EU) 2017/745), with the involvement of the Notified Body, as well as in complying with any formal requirements for the marketing of medical devices.
As part of the services offered, we also help our customers register their entities and MD in the EUDAMED database (European MD Database).
In addition, we provide full post-marketing support, including:
As a CDMO (contract development manufacturing organisation) we have been certified according to PN-EN ISO 13485:2016-04 for development and manufacturing of medical devices in the form of softgel capsules and liquids.
- Safety surveillance – Post-Marketing Surveillance(PMS) and Periodic Safety Update Reports (PSUR)
- Clinical follow-up after the marketing of medical devices — Post-Marketing Clinical Follow-up (PMCF).
Registration of medical devices
In the EU registration of medical devices is conducted by national authorities each Member State. We offer registration of devices in the EU. In 2022 the Eudamed data base will be fully operative to register medical devices within EU and we will provide you with the service of registration according to new rules.
New EU law – Regulation2017/745 (MDR)
In view of the amended EU law on medical devices, which has been applicable since 26 May 2021, we also provide assistance in adopting new requirements under the MDR (we perform analyses of medical devices for compliance with the MDR, including new classification rules).
Under the MDR, the ‘placing on the market’ means the first making available of a device, other than an investigational device, on the Union market, i.e., the supply of the MD for the purposes of distribution, consumption or use as part of the business activities carried out.
The Regulatory Affairs Department od Curtis Health Caps S.A. provides services related to the registration of business entities and medical devices in the EUDAMED database.
The scope of service includes:
- Substantive support on the funcjonality of the database, in particular the “Actor module”, including practical tips:
- how to register in the EUDAMED database,
- how to add new users to the EUDAMED database and manage their rights,
- what obligations arise from registration.
- Going through the process of registering a business entity together with the customer
- Assistance with the application for a unique registration number (SRN)
- Assistance with registration 3 medical devices in EUDAMED database
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