Services
Take advantage from both our company strongly established since 2008 and the related experience acquired as manufacturer for medical devices.
We speak the same language!
We act and provide services as Authorised Representative (AR) for all medical devices. We establish strong regulatory support and documents conformity for Swiss market and EU. We follow full compliance protocol as per the market regulations and the revised Medical Device Ordinance (MedDO) or revised EU MDR (Reg. (EU) No. 2017/745). We train and keep up-to-date, our employees and our clients, on the latest modifications and amendments. We secure and communicate on post market surveillance and ensure the products are safe.
This is a non-exhaustive list
of our services in U-represent legal division
Regardless of the complexity of the product we will find you a solution. It is the aim of our action.
- Ensure privacy and full respect of confidential business information.
- Ensure full compliance with products registrations under MedDO and MDR.
- Store safely and in total privacy the copy of technical documentations, CoC, and all files requested under MedDO/MDR related to the products. Also, we make them available to the national authorities in case of demand during 10 to 15 years depending on the class of the products.
- Keep track on Post Market Surveillance (PMS) in Switzerland/EU and we communicate to the appropriate parties as fast as possible on any findings, claims or actions to take.
- Liaise with Swiss/EU authorities on audits and corrective actions. Also provide product samples and documents when requested.
- Offer labelling service in order to comply with swiss authorized representative regulations.
- We train and keep up-to-date, our employees and our clients, on the latest modifications and amendments. We secure and communicate on post market surveillance and ensure the products are safe for end users.
don’t wait any longer
CONTACT OUR TEAM TODAY!
Contact an experienced regulatory professional to start the registration
- info@u-represent.com