Medical devices and IVDs

We offer comprehensive expert services covering the entire product life-cycle of medical device and in vitro diagnostic device. Utilise 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 the preparation of the required documentation. If your product is already on the market, you can outsource any post-marketing duties to us.

Services

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  • CE marking
    • • Product classification and selection of suitable procedures for product
    •   conformity assessments (CE marking)
    • • Planning of content of technical documentation
    • • Writing of documents belonging to technical documentation
    • • Compilation of the whole technical documentation
    • • Compliance check with Essential Requirements
    • • Evaluation of existing documentation for CE marking purposes
    • • Updating of existing documents belonging to technical documentation
    • • Gap analysis between existing technical documentation and requirements
    •   of Medical Device Regulation 2017/745 or In Vitro  Diagnostic Regulation 2017/746
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  • Regulatory support
    • • Creation of regulatory strategy
    • • Regulatory representative in device development projects
    • • Regulatory representative in design/manufacturing change projects
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  • Product registrations
    • • Compilation of country-specific product registration files
    • • Clarification of country-specific product registration requirements
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  • Clinical evaluations and performance evaluations
    • • Product-specific strategies to meet clinical data requirements
    • • Writing of clinical evaluation / performance evaluation reports
    • • Updating of clinical evaluation / performance evaluation reports
    • • Post-market clinical follow-up / performance follow-up activities
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  • Clinical investigations and performance studies
    • • Selection of an appropriate study design
    • • Writing of study protocols and informed consent forms
    • • Site selection and agreements
    • • Independent ethics committee and CA approvals
    • • Data management and statistics
    • • Reporting of study results
    • • Quality assurance
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  • Quality management
    • • Consultation on requirements, establishment and implementation of quality management system
    • • Quality management system (pre-)audits and gap-analyses, coordination of internal audit programs
    • • Coordination of supplier management, vendor and supplier audits
    • • Coordination of post-market surveillance activities
    • • SOP writing, review and consultation
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  • Risk management
    • • Coordination of risk management activities
    • • Writing of risk management plans, risk analyses and risk management reports
    • • Writing of SOPs for risk management
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  • Borderline issues
    • • Clarification of borderline issues e.g. for unambiguous classification of your product
    • • Communication with notified bodies and authorities
    • • Classification requests to authorities
    • • Switches of product classification (e.g. drug -> medical device)
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  • Incidents and field safety corrective actions
    • • Consultation on whether the incident / field safety corrective action (FSCA) is reportable
    • • Compilation of incident / FSCA documentation including authority reports and field safety
    •   notices, coordination of internal investigations
    • • Reporting to authorities
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  • 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
      • • Medical Device Regulation 2017/745 / In Vitro Diagnostic Regulation 2017/746
      • • EN ISO 13485:2016
      • • 21 CFR Part 820 (QSR)
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  • Laboratory services / R&D (drug-like devices)

For more information please contact

Regulatory Affairs Expert Päivi Turta