Nous ne nous contentons pas de livrer des documents ; nous bâtissons des partenariats stratégiques qui transforment la complexité de l'EU MDR en avantage compétitif pour les fabricants de dispositifs de Classe II et III.
Nihon Kohden required a partner to restructure Japanese clinical documentation logic into the specific language and rigor expected by European Notified Body reviewers for the EEG-1200K.
"Eclevar shared their expertise in a way that allowed us to create documentation perfectly adapted to our needs. The team responded promptly and flexibly."
— Product Manager, Nihon Kohden Corporation
For Asahi Intecc, Eclevar transformed complex Notified Body inquiries into a structured response strategy. Our color-coded gap evaluation identified compliance issues with absolute clarity, leading to a successful review with zero Major Non-Conformance Reports.
"The evaluation pinpointed areas needing improvement with color-coded clarity. Eclevar's insights have been instrumental in addressing inquiries from the Notified Body."
— Seiichi Tanaka, ASAHI INTECC
Eclevar dirige toutes les études PMCF à venir sur les dispositifs d'ulcère du pied diabétique chronique pour RegenLab (présent dans 160 pays).
"Eclevar, with its tailor-made approach and advanced MILO Studio platform, represents a major strategic asset." — Antoine Turzi, CEO
Analyse de l'impact de MILO sur 150 patients atteints de plaies chroniques.
Retour d'expérience sur la rationalisation de la documentation clinique via notre plateforme.
Strategic support for ophthalmology and contact lens medical device compliance across European markets.
Comprehensive clinical and regulatory solutions for complex renal and cardiovascular medical device portfolios.
Dedicated clinical evaluation and post-market evidence generation for advanced dental and restorative technologies.
RWE · Rare Diseases · Global CDMO
Unither Pharmaceuticals partnered with Eclevar to collect Real-World Evidence on ORL devices for rare disease patients. We overcame the dual challenge of EU MDR compliance and specific patient identification across four continents.
"Eclevar's expertise allows us to save valuable time and feel confident about regulatory acceptability."
— Nathalie Masson, Director of Innovation, Unither
USA to EU MDR Bridge · Wound Care
Bringing a US wound care portfolio into EU MDR compliance requires a specific methodology to bridge FDA logic with European expectations. Gentell engaged Eclevar to lead this regulatory bridge for their full advanced dressing catalog.
"Bridging the gap between US clinical data and EU MDR requirements requires deep vertical expertise in wound care."
— Regulatory Affairs Lead, Gentell
