ALTRION provides regulatory affairs, quality and market access consulting services for medical device, in vitro diagnostic medical device, cosmetic and borderline product manufacturers seeking to enter, maintain or expand their presence in regulated markets. We support manufacturers with EU MDR and IVDR compliance, European Authorized Representative services, Swiss Authorized Representative services, UK Responsible Person services, U.S. Agent support, technical documentation review, PMS/PMCF/PSUR activities, cosmetic product compliance, product classification, registration support and international market access strategy.
Our approach combines regulatory expertise, technical understanding and practical business support. We help manufacturers define the correct regulatory pathway, prepare and maintain compliant documentation, assess the correct regulatory status of products, interact with economic operators and authorities, and manage post-market obligations efficiently. Whether you are launching a medical device, an IVD, a cosmetic product or a product at the borderline between regulatory frameworks, ALTRION helps you structure the process clearly and access regulated markets with confidence.
Our priority at Altrion is to ensure your success.
To do this, we help you:
- achieve regulatory compliance;
- improve the effectiveness of your organization;
- improve performance;
- expand your business.
We are here to ensure that the process is well planned and executed.
Our team has experience in a wide variety of business processes, which is why
we assure you that you will achieve the best results every time.
