Eco-design and environmental performance of medical devices — Meeting market expectations
Hospital buyers, notified bodies and commercial partners now incorporate environmental criteria into their assessments. Mastering the eco-design of medical devices is no longer a differentiating advantage: it is a condition of competitiveness. This one-day training gives R&D, marketing and CSR teams the conceptual benchmarks, practical tools and market arguments to steer the environmental performance of their products.
Audience R&D project managers, design engineers, product marketing managers, CSR managers and project officers, operational directors involved in product strategy.
Learning objectives
- ▸ Position the environmental challenges of the medical device sector within the applicable regulatory and standards framework (European Ecodesign for Sustainable Products regulation, AGEC law, ISO 14006, LCA)
- ▸ Identify the specific expectations of public hospital buyers and commercial partners regarding the environmental performance of medical devices
- ▸ Apply a structured eco-design approach to the life cycle of a medical device, from design to end of life
- ▸ Select and implement life cycle assessment (LCA) tools suited to the constraints of the medical device sector
- ▸ Build credible environmental communication that complies with the eco-declaration requirements applicable to medical devices
- ▸ Identify the environmental performance indicators relevant to a product-oriented CSR dashboard
Expected outcomes
- ✓ At the end of the day, participants have an operational method for integrating eco-design into their product development process, a map of the applicable frameworks, and structured arguments to promote the environmental performance of their medical devices to buyers and partners.
Accessibility & entry conditions
Access lead time
Registration up to 10 working days before the start of an open-enrolment session. In-house sessions can be scheduled within 3 to 4 weeks.
Prerequisites
No formal regulatory prerequisites. Professional experience in the medical device sector (R&D, marketing, quality or management) is recommended to get the most out of the discussions.
Disability access
Any disability situation can be accommodated. Contact our officer before registration to explore possible adjustments (equipment, materials, pacing). Contact our officer →
Funding
- ·This training is not Qualiopi-certified and is not eligible for OPCO funding
- ·Funding from own funds or the company's training budget
Detailed programme
A phone interview or positioning questionnaire is sent ahead of the session to calibrate the level, identify expectations and tailor the case studies to participants' real situations.
- 01
Context and challenges of the environmental performance of medical devices (1 h 30)
- ·Overview of the applicable regulatory and standards framework: European Ecodesign for Sustainable Products regulation (ESPR), AGEC law, RoHS directive, ISO 14001 and ISO 14006 standards
- ·Decarbonization roadmap for healthcare products in France
- ·Sectoral challenges and measured impacts of the medical device sector on the environment
- 02
Market expectations: hospital buyers, tenders and partners (1 h 30)
- ·Integration of environmental criteria into public hospital tenders
- ·Expectations of purchasing groups (UniHA, RESAH)
- ·Practices of distributors and importers regarding eco-declaration
- ·Practical cases from recent consultations
- 03
Eco-design approach applied to the life cycle of a medical device (2 h)
- ·Steps of a structured eco-design approach according to ISO 14006
- ·Simplified life cycle assessment (LCA): principles, tools suited to medical devices, interpretation of results
- ·Identification of improvement levers by phase (materials, manufacturing, packaging, transport, end of life)
- ·Linkage with ISO 14971 risk management and design according to MDR
- 04
Environmental communication and market promotion (1 h 30)
- ·Eco-declarations and environmental self-declarations: requirements of the ISO 14021 standard
- ·Environmental labelling, labels and certifications relevant to medical devices
- ·Avoiding misleading claims (greenwashing): legal framework and best practices
- ·Structuring a product environmental sales pitch aimed at hospital buyers and commercial partners
- 05
Hands-on practice and individual action plan (30 min)
- ·Exercise positioning one's organization in relation to the frameworks covered
- ·Building an eco-design roadmap suited to one's context
- ·Questions and answers and sharing of experiences between participants
Assessment of learning
Assessment methods
End-of-day QCM (20 questions covering all modules) supplemented by a role-play exercise: positioning a fictitious medical device on a multi-criteria environmental performance grid.
Certificate
Training certificate issued by Isofac Group at the end of the training, subject to full participation in the entire day. This certificate does not constitute a certification recognized by the RNCP or the Specific Directory (RS).
Satisfaction and results
Satisfaction rate: Being measured
First learner survey campaign under way — data published once the statistical threshold is reached.
Training team
Training delivered by the ISOFAC ACADEMY teaching team, made up of consultants specialised in medical devices, quality and regulatory affairs. Depending on the module, the session is led by a specialist with hands-on operational expertise in MDR compliance, ISO 13485 quality management systems, ISO 14971 risk management, clinical evaluation, technical documentation, regulatory audits and CE marking strategy.
Our trainers support manufacturers, distributors, importers, authorised representatives and other economic operators on a daily basis in bringing their medical devices into compliance. See the team's profiles →
Technical resources
In-person
Room equipped at the client site or in a partner centre (Montpellier, Lyon, Paris). Video projector, flipchart, printed materials.
Remote
Zoom (corporate) platform for the virtual classroom. Materials provided in PDF + access to additional resources for 12 months after the session.
Learner equipment
A connected computer with camera and microphone for remote sessions. No software to install.
Materials provided
- ·Session slideshow in PDF format
- ·Summary sheet of key frameworks
- ·Customizable eco-design action plan template
Post-course follow-up
Advice line
Hotline included for 30 days after the session for operational questions arising back on the job. Reply within 48 working hours.
Follow-up review
3-month review sent to the sponsor for in-house courses: feedback on the skills put into practice and any residual points.
Open-enrolment price (excl. VAT)
790 €
EU VAT applicable depending on the buyer's status.
In-house price
On request, depending on headcount and location.
Funding
- ·This training is not Qualiopi-certified and is not eligible for OPCO funding
- ·Funding from own funds or the company's training budget
Personalised quote within 48 hours.
Would you like to attend this course?
Tell us your preferred format (open-enrolment, in-house or virtual classroom), the number of participants and your schedule. We will get back to you within 48 hours with the next available dates and a firm quote.