Medical devices and IVDs

We offer comprehensive expert services covering the entire product life cycle of medical devices and in vitro diagnostic devices. Utilizing our expertise in your product development projects to ensures that all regulatory requirements are taken into account from the beginning. Our team will guide you through the CE marking process and assist in the preparation of the required documentation. If your product is already on the market, you can outsource any post-market duties to us.

Regulatory support

By utilizing our team’s extensive experience in your product development projects, you ensure that all regulatory requirements are considered early from the onset. We can enhance your device development projects by acting as regulatory representatives, or independent reviewers, or we can assist you in specific tasks including.:

  • Creation of regulatory strategy
  • Determination of the intended purpose
  • Clarification of borderline issues e.g. for unambiguous classification of your product
  • Switches of product classification (e.g. drug → medical device)
  • Gap analysis between existing technical documentation / design documentation and regulatory requirements (e.g. Medical Device Regulation 2017/745 or In Vitro Diagnostic Regulation 2017/746)

Medfiles has expertise to assist you with Drug-device Combination Products as well.

CE Marking and Product Registrations

Got a product falling under the definition of a medical device? If you are planning to get your product on the market in the EU, we can guide you through the CE marking process. Our team is experienced in successful product registrations in cooperation with local representatives in several markets around the world. We can assist you in:

  • Product classification and selection of suitable procedures for product conformity assessments (CE marking)
  • Planning of content of technical documentation
  • Compilation of documents belonging to technical documentation
  • Evaluation of existing documentation for CE marking or registration purposes
  • Compilation of country-specific product registration files

If your product is already on the market, you can outsource any maintenance activities to us.

Clinical Evaluations and performance Evaluations

Clinical evaluation/ performance evaluation is an essential part of the conformity assessment of medical devices/ IVDs. The bar has been rising in clinical data segment and the question of whether there is enough clinical data available from equivalent products or if clinical investigations are needed is of critical importance. No matter if you plan to tackle the requirements with review of published literature or clinical investigations of your own, we can provide the expertise and resources in:

  • Creating product-specific strategies to meet clinical data requirements
  • Writing of clinical evaluation and performance evaluation plans and reports
  • Planning, performing and reporting systematic literature reviews
  • Clinical investigations and performance studies
  • Writing of post-market clinical follow-up and performance follow-up plans and reports and assisting in PMCF/PMPF activities

Quality Management

Most major markets require implementation and maintenance of a quality management system. ISO 13485 is an international quality management system standard for medical devices that has been developed to meet the specific needs of the industry. Several markets, however, have their own specific requirements. Let us help you in establishing and implementing the requirements from your market areas into an efficient QMS system by: 

  • Providing an ISO 13485 based QMS package
  • Consulting on requirements, establishment, and implementation of quality management system
  • Performing quality management system (pre-)audits and gap-analyses
  • SOP writing, review, and consultation

You may also choose to outsource quality manager/ quality specialist tasks with us including e.g.:

  • Personnel responsible for regulatory compliance
  • Coordination of internal audit programs, conducting internal audits
  • Coordination of supplier management, conducting vendor and supplier audits
  • Coordination of post-market surveillance activities
  • Coordination and performance of risk management activities

Post-market Surveillance and Vigilance

Do you need help in creating a post-market surveillance system that meets all applicable regulatory requirements? Our experts can support you in establishing or developing your post-market processes or you can outsource us parts of your process if you need an extra pair of hands.

Our services include: 

  • Consultation on post-market surveillance, post-market clinical follow-up/ performance follow-up
  • Consultation on vigilance procedures
  • Coordination of post-market surveillance activities
  • Specific tasks related to PMS/PMCF/PMPF (e.g. systematic literature reviews, vigilance database searches)
  • Incident and field safety corrective action processing and reporting 

Additional Services

Medfiles and our experienced medical device and IVD teams can provide a diverse range of services to assist you in a variety of situations. You can benefit from our experience and know how e.g. with following additional services:

  • Trainings tailored to customer needs. Examples of possible topics:
    • CE marking process of medical devices – requirements and practices
    • Medical Device Regulation 2017/745 or In Vitro Diagnostic Regulation 2017/746
    • EN ISO 13485:2016
    • 21 CFR Part 820 (QSR)
  • Support/ coaching for your quality/ regulatory affairs personnel
  • Laboratory services / R&D (drug-like devices):

For more information please contact

Let’s chat