Evnia announces a new strategic partnership with Rallis-Daw Consulting LLC in the fields of strategic regulatory planning and support of medical device manufacturers for regulatory compliance and clinical development within the framework of EU-MDR and FDA affairs.
Rallis-Daw Consulting and Evnia share the same business ethics and prioritize patient safety through the development of innovative and tailored approaches/tools for medical device manufacturers.
”Our partnership with Evnia marks a pivotal moment in our company’s journey. As we expand our footprint side by side, we are further equipping our clients with the crucial tools required to bring groundbreaking and disruptive devices to the market both domestically and internationally” said, Stephanie Rallis-Daw, President & CEO, Rallis-Daw Consulting.
Rallis-Daw Consulting operates to the same high standards as Evnia with a focus on full quality management system implementation (QMS/eQMS) and comprehensive programs to guide innovators through the entire product development lifecycle also by partnering with key organizations to enable the provision of their Napkin-to-Market™ and beyond program.
”Our partnership with Rallis-Daw Consulting is a milestone of our journey towards healthcare innovation. This new collaboration will act as a catalyst for our partners and clients, who will have access to a larger network of services and know-how. Together, we continue to transform clinical and regulatory intelligence into actionable solutions” said Dr. Efstathios Vassiliadis, CEO, Evnia Group.
About Rallis Consulting
Rallis-Daw Consulting LLC is a San Clemente, CA USA-based, woman-owned business founded in 2021, which offers a wide array of services to the life sciences industry including
- Full Quality Management System (QMS) Implementation (eQMS or paper-based)
- Ablest-eQMS™
- Napkin-to-Market™
- Regulatory Submissions
- QMS and Regulatory File Gap Analyses and Remediation
- Internal Audits including MDSAP, EU MDR, etc.
- Supplier Audits
- Risk Management Execution
- Verification, Validation, and Qualification test protocol and report writing
- Statistical Analyses
- EU MDR and QMSR transition support
- Mentoring and more.
With over 30 consultants, who hold an average of over 20 years of experience across multiple disciplines, Rallis-Daw Consulting LLC has successfully completed 750+ audits and has brought over 10 medical devices to the market.
Giving back is one of the core values at Rallis Consulting LLC. More than 5% of all earnings are given back to causes. Some of the organizations we give back to include St. Jude Children’s Research Hospital, Boys and Girls Club of the South Coast Area, Meals on Wheels, and much more.
About Evnia
Evnia was founded in Denmark in 2015 in Copenhagen with the vision of becoming the missing link between manufacturers, regulators, and investors coworking for the time-effective commercialization of innovative medical devices and in-vitro diagnostics.
Headquartered in Denmark, Evnia currently has offices in the UK, Greece, and Italy but we are servicing manufacturers globally. Evnia has been certified under ISO 9001:2015 as a clinical and regulatory affairs consulting agency within the life sciences industry.
Dedicated to the acceleration of healthcare innovation and patient safety, we offer a cluster of interconnected services from the early stages of a medical device’s lifecycle until its post-market adulthood in the fields of
- Due Diligence
- Regulatory Strategy
- Clinical Development Strategy
- Post-Market Surveillance
- Real World Evidence
- Market Access and Reimbursement
- EU and UK Representation Services
Our full-value-chain services are supported by a growing, cross-functional team of medical writers, medical doctors, usability, risk and validation engineers, biostatisticians, biocompatibility executives, and clinical and regulatory affairs experts with long field experience. Our in-house human resources enable the development and implementation of holistic and customisable solutions.
Evnia specializes in strategic regulatory and clinical planning for start-ups as well as the generation, collection, appraisal, and interpretation of real-world clinical data. Our goal is to leverage our internal, standardized processes to assist manufacturers achieve and continuously operating within a compliance continuum.
