EGGS partners with CENIT Consulting for Med Tech compliance
Will ensure ISO 13485 compliance in client projects
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The health sector is highly dependent on tech and innovation to handle its challenges. To ensure that we offer our clients a complete and secure innovation process, we are partnering up with Med Tech regulations experts CENIT Consulting, securing ISO standard compliance.
Expertise in international regulations
CENIT Consulting is a strategic compliance partner with the regulatory affairs expertise that EGGS needs to secure that our healthtech and Med Tech projects adhere to current EU and overseas regulations. This enables us to focus on what we know and do best – value-driven innovation within healthtech – while knowing that our clients’ regulatory demands are secured.
“By partnering with CENIT, we can offer our clients a holistic process, from ideation and user insight to certified product. It ensures that clients get the best of both worlds – innovation know-how and regulatory expertise.”Sigrun Vik, Head of Health, EGGS Design
About ISO 13485
The ISO 13485 standard specifies regulations for organisations that provide medical devices and related services. This applies to organisations involved in one or more product life cycle stages, including design and development, production, storage and distribution, installation or servicing of a medical device, and design and development or provision of associated activities (e.g., technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide products, including quality management system-related services to such organisations.
"We’re excited to partner with EGGS Design, a company that brings innovative solutions to the med tech industry. We’re looking forward to helping even more companies bring life-changing medical devices to market, ultimately improving patients' lives."Eirik Lima, CEO, CENIT Consulting
