Manufacturing of medical devices

Solid form - soft capsules
Liquid form

 

As part of the design and manufacturing of medical devices::

  • the evaluation of the proposal (composition, route of administration, intended use of the device)
  • determining the correct classification of the medical device
  • preparation of trial and pilot batches of medical devices
  • development of technical documentation along with clinical evaluation
  • conducting a full conformity assessment of the medical device (considering the device’s classification)
  • conducting certification with or without the involvement of a notified body
  • registration of a medical device
  • conducting an audit of technical documentation
  • support in adapting to the new MDR requirements (analysis of the device for compliance with MDR, new classification rules)
  • post-market surveillance of the medical device (PMS)
  • post-market clinical follow-up (PMCF)
  • manufacturing and development of the medical device in accordance with applicable law

Comprehensive service for every client

Curtis Health Caps has a state-of-the-art technological facility and a team of skilled specialists, allowing us to offer comprehensive contract manufacturing services for medical devices tailored to client needs. As a medical device manufacturer, we handle the entire production process – from developing the formulation to creating the final product, including the development of the documentation required for its release to the market. Depending on the current needs of our clients, we handle both the comprehensive manufacturing of medical devices and individual stages of the process. This means that we can be both a manufacturing site and a manufacturer of a medical device according to the definitions of the applicable law. In contract manufacturing of medical devices, we maintain the highest production standards, complying with Good Manufacturing Practice (GMP), the HACCP system requirements, and PN-EN ISO 13485:2016 standards. We also offer our clients registration and manufacturing services for medicines, as well as contract manufacturing of dietary supplements.