Regulatory Affairs

We help you to develop an effective regulatory strategy for Europe, Canada and US market clearance. We focus on a short product development cycle, and determine the requirements for the Quality Systems of medical devices. In order to shorten the product development cycle, medical device manufacturers need to identify as early as possible the world-wide regulatory requirements for new or modified products. Until global harmonization is reached, it is important to develop supporting documents which are in compliance with European, Canadian and US requirements for product submissions. VISAMED can assist you in:

  • Training on Regulatory affairs
  • Register existing Medical Devices with a UDI in the GUDID database
  • Developing an effective regulatory strategy for Europe, Canada and US market clearance
  • Determining the applicability of the European, Canadian and US requirements/guidelines/standards
  • Determining the European and US Quality Systems requirements

Europe

To receive in a timely manner the market clearance in Europe, VISAMED supports you in the following activities:

  • Strategic review and planning to achieve device CE marking
  • Device classification
  • Conformity assessment procedures
  • Notified body selection and coordination
  • Pre-assessment certification review audit
  • Technical file/dossier preparation
  • Essential requirements
  • Clinical evaluation: Literature research and analysis to support product safety and efficacy
  • Risk analysis and risk management
  • Labeling
  • Translation of technical documentation including labeling
  • Compliance with post-market surveillance requirements

Canada

To receive in a timely manner the market clearance in Canada, VISAMED supports you in the following activities:

  • Strategic review and planning to archieve Canadian medical device license clearance
  • Device classification
  • Conformity assessment and standard identification
  • Labeling Creation
  • Preparation of medical device license applications
  • Compliance with post-market surveillance requirements
  • VISAMED can be your Authorized Representative in Europe

USA

VISAMED as a European based consulting firm can provide local assistance to European medical devices manufacturers regarding US product submission requirements especially for complex devices and devices containing software. VISAMED supports you in the following activities:

  • Obtaining US guidance documents and standards
  • Interpretation of US submissions requirements
  • Review draft submission documentation (IDE, PMA, 510(K), HUD for example)
  • Assisting you in the development of labeling, including user manuals, that meets US regulatory and customer requirements
  • For specific projects, directly translating or arranging the translation of documents and labeling required for the submission
  • VISAMED can be your Authorized Representative in Europe