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Regulatory Affairs
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 Regulatory Support
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
Canadian Regulatory Support
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
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
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Tel. +49(0)721-4764847