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Regulatory framework for medical devices : How to turn it into an ally for your documentation

    Context

    The enforcement of MDR 2017-745 raises a number of difficult questions:

    • Do we actually own the content of our technical documentation? Is our data analysed, synthesized and justified?
    • Will our Quality Management System be compliant with all requirements of article 10, paragraph 9 of MDR before 2024/05/26?
    • Will we have deposited the formal certification request for each device before 2024/05/26 to a designated Notified Body?
    • Will we have a signed contrat with the Notified Body, covering each and every one of our devices before the 2024/09/26 ?

    Right until a medical device is certified, it does not really exists in the eyes of the world. What exists can be read through technical files, test reports, purchase contracts, biocompatibility, reports of clinical investigation and all the documentation produced by all departments throughout the conception, development and manufacture of the device.
    Experience shows that the alignment between the necessary information required to obtain the CE marking and their production is incomplete. Consequences of this misalignment range from delay to reach the market to the end of service for a manufacturer.

    Turning the regulatory framework into an allay begins by training the departments into information alignment. Needs are clarified, processes are co-defined, team members are fluent with the necessary tools, change is accepted and teams are on board.

    For whom ?

    • Quality departments in medical device industry
    • Regulatory affairs departments in medical device industry
    • Research and Development departments in medical device industry

    Pre-requisites

    Context

    • Work in R&D or QARA
    • During one’s professional activity, bump into technical data misalignements that hamper the execution of the position’s missions
    • Be willing to break what does not work, and co-establish operational information flows for all parties involved

    Requirements

    • Know the process of conception and development for a medical device
    • Know the regulatory framework that accompanies a medical device to the market. At least, be aware of it
    • Currently writing one or more technical documentation for submission to a notified body

    Objectives of the training

    “Turning the regulatory framework into an ally” trains teams to realign information flows. Needs are clarified, processes are co-defined, team members are fluent with the necessary tools, change is accepted and teams are on board

    • Self-analyse the information maturity of each department
    • Identify blocking points that prevent information from flowing between departments
    • Co-build tools, processes, KPIs that show proper information flows
    • Identify levers for action
    • Provide arguments to C-level executives

    Programme complet

    D-14

    • Individual interviews
    • Positioning questionnaire

    Day 1

    Pedagogical objectives

    • Self-analyse the information maturity of each department
    • Identify blocking points that prevent information from flowing between departments

    Steps

    • Inclusion
    • Portrait game
    • Pain point reveals the need
    • Pain point in context. How does this information contribute to the company’s objectives?
    • Portraits reboot and persona creation
    • Empathy map creation
    • Formative evaluation

    Day 2

    Pedagogical objectives

    • Co-build tools, processes, KPIs

    Steps

    • Root-cause analysis of the pain point
    • Identification of responsibilities
    • RACI matrix creation of this information need, based on information collected the previous
    • Categorisation of information types
    • Co-creation of information flow
    • No limits: what is needed for this to work?
    • Formative evaluation

    Day 3

    Pedagogical objectives

    • Identify levers for action
    • Provide arguments to C-level executives

    Steps

    • Review of material created: persona, empathy maps, RACI matrix
    • Self-attribution of items for fluid information flow
    • What do we do now?
    • Train to argue with decision-makers
    • What do we do now, what did we learn? Strong ideas, strategies, chaining of arguments
    • Wrap-up
    • Hot from the press evaluation of the training

    After the training

    3 weeks after the training

    • Cold-headed evaluation of the training

    3 months and 5months after the training

    • Impact assessment of the training

    Pedagogy

    Active pedagogy

    • Study of real case
    • Co-analysis of situations
    • Co-construction of tools
    • Co-construction of solutions
    • Co-construction of indicators
    • Usage of newly acquired know-how

    Theoretical contributions

    • RACI matrix: roles and activities
    • Tools to identify blocking points
    • Formalising of processes and associated procedures
    • Creation of lines of arguments
    • Digital resources will be available at the end of the training

    Evaluation

    • Positioning questionnaire before the registration of each participant
    • Formative evaluation (during the training)
    • Summative evaluation (at the end)
    • Hot from the press evaluation: Satisfaction questionnaire provided at the end of the training, to be filled individually
    • Cold-headed evaluation: Questionnaire addressing the new competencies and tools, what has been learned, provided 3 weeks after the training
    • Impact assessment: conducted by group and individual interviews, 5 months after the end of the training
    Inter

    Inter-company

    In-person duration : 3 day(s) / 18 hour(s)
    In-person duration : 3 day(s) / 18 hour(s)
    Inter-company period before training : 21 days

    Fare : 2600 € net of tax per person participating

    Minimum participants per inter-company session : 4
    Maximum participants per inter-company session : 8

    Intra

    Intra-company

    In-person duration : 3 day(s) / 18 hour(s)
    In-person duration : 3 day(s) / 18 hour(s)
    Period before on-demand training : 21 days

    Fare : 3800 € net of tax

    Minimum participants per inter-company session : 4
    Maximum participants per inter-company session : 8

    Sur-mesure

    In-person training

    In-person duration : according to needs
    In-person duration : according to needs
    Maximal duration of in-person training, in days : 5 days
    Period before on-demand training : 30 days

    Fare : contact us

    Minimum participants per on-demand session : 4
    Maximum participants per on-demand session : 8

    Next sessions

    Contact us for dates

    Référence :

    Locations : Europe, north america. For other locations, please contact us.

    Information request