Deirdre Caheny

Arrotek’s Modular Approach to Medical Device Design and Development Services

by Deirdre Caheny
Our modular approach to the delivery of medical device design and development services means we can help with whatever level of support you need, whatever expertise you need, and wherever you are in the development process. While there are similarities across all medical device design and development projects, our experience at Arrotek is that every project is different. As a result, we have experience in everything from providing consultancy services to handling a single element of a larger project to providing full end-to-end services from ideation to commercialisation. With our modular approach, we can slot in wherever you need us,...

What is an EU Authorised Representative, When Do You Need One, and What Do they Do?

by Deirdre Caheny
According to the EU MDR (European Union Medical Device Regulations), medical device manufacturers must, in some circumstances, appoint a European Authorised Representative in order to obtain CE certification for their products so they can be sold in Europe. What is a European Authorised Representative, though? According to the definition in EU regulations, an Authorised Person must be a "natural or legal person" in the EU. The main role of an Authorised Representative is to represent the manufacturer in dealings with EU regulators. If you are a European-based medical device manufacturer, you will deal directly with regulators. There is no need...