Regulatory Affairs

Product certification within Europe and internationally

We handle for you the:

• Certification of medical products within Europe (CE marking)
• Certification of medical products in the US (UL approval)
• Preparation of documents required for the certification process
• Provision of prototypes for the certification authorities
• Correspondence with certification authorities

Everything from one source

Product certification for European and global markets are core competencies for Ondal. By providing this service, Ondal markedly facilitates the process of bringing new product developments to market-readiness for its customers. Ondal ensures that the future product is in compliance with the certification requirements as early as during the development phase. Ondal conducts all inspections and tests required for the product to pass certification.