Medical devices

We offer comprehensive expert services covering the entire product life-cycle to medical device and in vitro diagnostic device companies. Utilize our expertise in your product development projects to ensure that all regulatory requirements are taken into account early enough. We guide you through the CE marking process and assist in preparation of the required documentation.  If your product is already on the market you can outsource us any post-marketing duties.

Services

  • Borderline issues
    • • Clarification of borderline issues
         e.g. for unambiguous classification of your product (drug, device, food, cosmetic, biocide)
    • • Identification of correct process for marketing authorisation of borderline products
    • • Communication with notified bodies and authorities
    • • Classification requests to authorities
    • • Switches of product classification (e.g. drug -> medical device)
    • • CE marking of drug-like medical devices

  • CE marking
    • • Product classification and selection of suitable procedures
      for product conformity assessments (CE marking)
    • • Planning of content of technical documentation
    • • Writing and compilation of technical documentation / design dossier
    • • Evaluation and updating of existing technical documentation
    • • Selection of a Notified Body and relevant coordination activities

  • Clinical evaluations
    • • Product-specific overviews to meet clinical data requirements
    • • Writing of clinical evaluations
    • • Updates of clinical evaluations
    • • Literature searches of clinical data

  • Biological evaluations
    • • Consultation on requirements of biological evaluations
    • • Assessments of sufficiency of biological data
    • • Writing of biological evaluations
    • • Updates of biological evaluations
    • • Literature searches of biological data

  • Risk management
    • • Risk management files of devices
    • • Risk management systems and procedures
    • • Clinical expertise in risk analysis

  • Training
    • • Trainings tailored to customer needs. Examples of possible topics:
      • • What is a medical device? – Overview of product classification and borderline issues
      • • CE marking process of medical devices – requirements and practices
      • • Labelling requirements of medical devices
      • • Role of quality system in CE marking of medical devices

  • Clinical investigations and performance evaluations
    Clinical development

For more information please contact

Regulatory Affairs Manager Laura Petäjämäki