Regulatory Strategy
One of the most important processes for a product and a company in the development phase, is the formulation of the regulatory strategy. This document describes the intended use, product claims, potential predicative analysis and a thorough risk/benefit analysis. This will illustrate the best regulatory pathway for the product itself and for the company.

Classification
Qmed Consulting ApS has solid experience within regulatory affaires. We guide you through the rules of medical device classification. We have access to the international standards and guidance documents that your company have to or may choose to follow.

Design Dossiers and Technical Files
Qmed Consulting ApS work out design dossiers and technical files. We have experience in communicating with notified bodies and we assist you in the Registration process in Europe (EU) and contries outside EU e.g. Japan and US. 

Qmed Consulting may act as Authorized representative in Europe for companiesoutside EU.

We have a network of experts in the US who have extensive knowledge of the FDA and the individual forms of approval.

Post-Market Surveillance
Increasingly PMS has the authority’s interest. Qmed Consulting ApS will assist you in setting up a PMS program based on either post market clinical trials or the evaluation of clinical literature and other internal routes of documentation.

We are experienced in gathering documentation to support your communication with the authorities.