VISAMED Consulting Services for Medical Industries 

Regulatory

European, Canadian and US regulatory affairs

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

  • 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

European/Canadian Regulatory Support

To receive in a timely manner the market clearance in Europe and/or Canada, 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

US Regulatory Support

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
 
Send mail to info@visa-med.com with questions or comments about this web site.