EXPERIENCE THAT MATTERS
We are a strong team with long experience covering quality and regulatory management for medical devices. With the base in ISO 13485, ISO 14971, MDR and IVDR as well as additional applicable standards. The team has experience from companies such as small start-ups in more generalist roles to large corporations where specific knowledge is key covering fields e.g. dentistry, ventilation, x-ray, medical device, software, and combination products.