Quality & CE marking
At NAALA, we specialize in providing expert advice on quality and CE-marking for innovative products. We understand the importance of meeting regulatory requirements and ensuring your software product meets the highest quality standards. Our team of experienced legal professionals can guide you through the entire process, helping you navigate the complexities of CE-marking and ensuring compliance with relevant regulations. With our in-depth knowledge of the industry and regulatory landscape, we can help you streamline your quality management systems, conduct risk assessments, and achieve CE-certification for your software products, enabling you to confidently bring your innovative solutions to market.
Medical Devices Regulation
We can help ensuring your medical device meets European requirements.
ISO 13485, ISO 14971, ISO 60601, ISO 60304.
In Vitro Diagnostic Devices Regulation
We assist in implementing management systems that ensure compliance.
ISO 13485, ISO 17025, ISO 14971, ISO 60601, ISO 15189
Artifical Intelligence Act
We provide our expert advice to ensure safe and effectice AI-systems.
ISO 9001, ISO 14971, ISO 62304.
How do you want to implement requirements?
Want to do it yourself? We have templates for Confluence, Notion and Microsoft 365 that serve as a wiki to guide you and your team through implementation.
€3000,-
Do you wish to always have access to our expertise? For a monthly fee, we become part of your team and ensure your compliance and audit readiness throughout the year.
starting at €1000,- a month
Receive tailored legal support designed specifically to meet the unique needs and requirements of your company.
€ Dependend on your needs
€3000,-
starting a €1000,- a month
€ Dependend on your needs
