Turning MedTech Innovation into Market-Ready Success
Strategy, experience and execution across clinical evidence, regulatory affairs and quality.
JeFa Group supports MedTech companies from early development to regulatory approval and market – combining strategic guidance, senior expertise and hands-on implementation.
Experience Where It Makes a Difference
From a specific challenge to a broader strategic assignment, JeFa Group adapts the support to your needs and stage of development.
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01
Clinical Evidence & Clinical Affairs
Evidence strategy, clinical development and clinical evaluation supporting regulatory and business objectives.
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02
Regulatory Strategy & Compliance
Strategic and hands-on support to navigate regulatory requirements and the path to market.
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03
Quality Management Systems
Development and implementation of scalable QMS aligned with ISO 13485 and MDR requirements.
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04
Leadership & Strategic Support
Executive advisory, interim leadership and organisational development when senior expertise and additional capacity are needed.
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From Direction to Results
Strategies create value when they are put into practice. JeFa Group combines strategic perspective with operational execution.
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ORIENTATE
Understand the need and define the direction.
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STRUCTURE
Create structure, priorities and responsibilities.
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EXECUTE
Turn the plan into action.
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GROW
Build on results, learning and evolving needs.
Senior Experience – Applied in Practice
JeFa Group was founded by Jenny Fäldt, PhD, bringing more than 20 years of experience from senior roles across MedTech, Clinical Affairs, research, regulatory strategy and innovation. Following global leadership roles at Mölnlycke Health Care, Essity and Nobel Biocare, Jenny today works as an advisor, consultant and interim executive supporting MedTech companies at different stages of development.
Need Senior MedTech Expertise or Additional Capacity?
Let’s discuss your needs and how JeFa Group can support you.