Eco-design of Medical Devices

Dernière mise à jour : 25/06/2026

Bannière visuelle de présentation de la formation

Description

In a context where environmental responsibility, regulatory compliance and sustainable innovation are becoming major drivers for medical device manufacturers and designers, integrating eco-design from the earliest stages of product development is now essential.

This intensive two-day training provides a comprehensive and operational approach to eco-design applied to medical devices, based on the NF X30-264 and ISO 14006 standard. It combines theoretical input, real-life case studies, collaborative workshops and practical tools to help participants understand how to identify environmental levers compatible with regulatory requirements (MDR, ISO 13485), assess real gains and communicate responsibly. This pragmatic approach equips professionals with the skills to structure and promote a relevant eco-design strategy adapted to the constraints of the medical sector.

Domaine : Dispositifs Médicaux

Objectifs de la formation

Understand the regulatory framework, the norms and challenges of eco-design applied to medical devices (NF X30-264, ISO 14006, ISO 13485, ISO 14971, MDR, ISO 14021).
Structure and manage an eco-design approach for the development or optimization of a medical device.
Identify and develop suitable eco-design technical solutions for medical devices.
Learn how to assess and validate environmental gains of an eco-designed system.
Understand how to build a sustainable integration and communication strategy.
Integrate eco-design throughout the medical device life cycle.
Eco-design with monitoring and continuous improvement.

Public visé

Medical device project managers, RA/QA, R&D managers, eco-design specialists, industrial designers, regulatory affairs professionals, medical device development consultants.
All audiences (MD / IVD industry).

Prérequis

No prerequisites

Programme

Introduction to Eco-Design / Applicable Frameworks

Key definitions: eco-design, life cycle, LCA, system
Regulatory overview (AGEC law, ESPR, PPWR…) and sustainable public procurement in France
Principes & steps to implement ecodesign based on the norms NF X30-264 & ISO 14006
Environmental challenges associated with medical devices (MDs) along its life cycle
Benefits of eco-design
Overview of other applicable standards and reference frameworks (ISO 13485, ISO 14971).

Framing a Medical Device Eco-Design Project

Context analysis
Analysis of the level of maturity of your company in terms of ecodesign and definition of the ambition of the ecodesign project

Environmental Impact Analysis of an MD

Selection of the appropriate “system” (MD, packaging, healthcare system) and the Functional Unit (FU) for a medical device: method, pitfalls, examples
Presentation of the main environmental Indicators in a Life Cycle Assessment (LCA)
Presentation of the tools to analyse environmental impact
Exercise : analyse your MD with the Index DM Durable, tool used by the purchasing department of public hospitals in France

Researching and Designing an Eco-Designed Solution

Presentation of Environment-oriented innovation methodology
Ecodesign guidelines for MDs
Multi-criteria decision methods (environment, cost, regulation, use)
Practical workshop on a real case

Assessing, Validating and Testing Gains

Check of potential rebound effects and impact transfers
Creating an eco-design solution validation sheet and its link with the validation file

Communicating on the Ecodesign Approach without greenwashing

Relevant claims (ISO 14021, NF X30-264)
Types of communication: internal / client / authority
Examples of admissible claims vs. greenwashing

Capitalization, Integration into QMS and PDCA

Compatibility with Design Control process (FDA / MDR), integration into QMS ISO 13485 (document control, management review, design review)
Basics of a medical device eco-performance dashboard
Link with the continuous improvement loop (PDCA) and with risk management (ISO 14971)

The first steps to implement your ecodesign project

Finding subsidies
Define a roadmap

Conclusion and Questions

Summary of the session and Q&A session
Resources to deepen knowledge
Evaluation MCQ

Modalités pédagogiques

This two-day programme is designed to provide a comprehensive introduction to eco-design of medical devices. Sessions are structured to encourage interactive discussions and hands-on exercises to ensure thorough understanding of the concepts presented.

Moyens et supports pédagogiques

Modules structured with objectives, covered topics and/or questions addressed, and timing for each module.
Teaching tools include games, examples, exercises, simulations and practical case studies.

Modalités d'évaluation et de suivi

Final assessment through a multiple-choice questionnaire (MCQ).
End-of-training satisfaction survey.

M'inscrire à la formation

Toutes nos formations sont accessibles aux personnes en situation de handicap, sous réserve que les conditions nécessaires à leur réalisation puissent être réunies.

Chaque situation étant unique, nous invitons les participants ou leurs employeurs à nous signaler toute situation de handicap dès la prise de contact ou lors de la demande de formation. Cette démarche nous permet d'étudier les possibilités d'adaptation, de mettre en œuvre les aménagements appropriés et de garantir des conditions de formation optimales.

Pour toute information complémentaire, vous pouvez également consulter les organismes spécialisés tels que l'AGEFIPH (www.agefiph.fr) et le FIPHFP (www.fiphfp.fr).

Nous tenons également à votre disposition une liste de partenaires pouvant être mobilisés, si nécessaire, afin d'accompagner la mise en place des adaptations.

All our training sessions are accessible to individuals with disabilities. As each situation is unique, we kindly ask our clients to specify the disability when making inquiries. This allows us to confirm all possible accommodations and enables participants to undergo training under the best conditions.

For further information, we recommend the following organizations: AGEFIPH (www.agefiph.fr), FIPHFP (www.fiphfp.fr). We also maintain a list of partners who can be mobilized if necessary.

Veuillez décrire votre situation

Vous ne trouvez pas de session correspondant à votre besoin ?

Si aucune date n’est affichée ou si les dates proposées ne vous conviennent pas, vous pouvez nous contacter via le formulaire de contact afin de nous faire part de votre besoin. Si plusieurs demandes sont enregistrées, une nouvelle session inter-entreprises pourra être programmée. Les participants seront alors informés des dates proposées dès leur ouverture. Si vous êtes responsable formation, vous pouvez également solliciter un devis pour l’organisation d’une session intra-entreprise. Après validation de la proposition commerciale, la formation peut généralement être organisée dans un délai de 4 à 8 semaines, sous réserve des disponibilités des intervenants et de vos contraintes d’organisation.

Can't find a session that meets your needs?

If no session is currently displayed, or if the available dates do not meet your needs, please contact us via our Contact page to let us know your requirements. If we receive multiple requests, a new open-enrolment (inter-company) session may be scheduled. Participants will be informed of the available dates as soon as they are published.

If you are a Training Manager, you may also request a quotation for an in-company (intra-company) training session. Once the commercial proposal has been approved, the training can generally be delivered within 4 to 8 weeks, subject to trainer availability and your organizational constraints.

S'inscrire

Catégorie : Règlementaire et conformité
Sous-Catégorie : Réglementation des Dispositifs Médicaux
Durée : 14h
Prix : 1 290 € HT

Prix INTRA : Nous consulter
Référence : QR291_EN
Satisfaction :

★★★★★

★★★★★
Taux de réussite : - %
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Vos formations

Les tarifs indiqués sont ceux pratiqués pour les sessions au format Inter-entreprise. Pour les sessions Intra-entreprises ou individualisées merci de nous contacter afin d'établir un devis.

The prices indicated are for sessions in the Inter-company format. For Intra-company or customized sessions, please contact us to establish a quote.

Prochaines Sessions

Vous ne trouvez pas de session correspondant à votre besoin ?

Si aucune date n’est affichée ou si les dates proposées ne vous conviennent pas, vous pouvez nous contacter via le formulaire de contact afin de nous faire part de votre besoin. Si plusieurs demandes sont enregistrées, une nouvelle session inter-entreprises pourra être programmée. Les participants seront alors informés des dates proposées dès leur ouverture. Si vous êtes responsable formation, vous pouvez également solliciter un devis pour l’organisation d’une session intra-entreprise. Après validation de la proposition commerciale, la formation peut généralement être organisée dans un délai de 4 à 8 semaines, sous réserve des disponibilités des intervenants et de vos contraintes d’organisation.

Can't find a session that meets your needs?

If no session is currently displayed, or if the available dates do not meet your needs, please contact us via our Contact page to let us know your requirements. If we receive multiple requests, a new open-enrolment (inter-company) session may be scheduled. Participants will be informed of the available dates as soon as they are published.

If you are a Training Manager, you may also request a quotation for an in-company (intra-company) training session. Once the commercial proposal has been approved, the training can generally be delivered within 4 to 8 weeks, subject to trainer availability and your organizational constraints.

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