How can JensonR+ help you?
We can support your devices & borderline products project and advise you every step of the way by finding the best conformity assessment route for your product.
We can generate relevant data to populate your technical file, advise on labelling and essential information, and create a full design dossier to expedite a rapid and appropriate registration for your product(s). We work directly with Notified Bodies and Competent Authorities to meet the Directive requirements for CE-marking, granting market access into the European Union.
We are able to act as an Authorised Representative or Manufacturer in compliance with ISO 13485 and 14971 and we can support your products with a full vigilance system, as required to address the needs of your business.
We also have experience of dealing with products that fall into the medicines borderlines area, such as cosmetics and food supplements.
Find out how we can help you by getting in touch with us today.