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REGULATORY AFFAIRS

Communicate – Iterate – Simplify

Entering a new market requires an understanding of the regulatory framework, good technical documentation and efficient processes for preparing applications and answering questions from regulatory authorities.

To achieve a broad market introduction you need a solid structure and good communications with authorities and local representatives.

Our consultants are results-oriented and are accustomed to navigating the global environment, both traditional and emerging markets. Today, we work primarily with medical products and offer services in the following areas:

 

  • Market Access
    • Preparation of submissions worldwide & CE-marking
    • Preparation of submission plans
    • Coordination/management of submission activities
  • Post market reporting
    • Authority reporting of complaints
    • Authority reporting of field corrective actions
  • Submission Planning
    • Adapting processes  to a changing regulatory landscape

Training in Regulatory Affairs


Find upcoming Regulatory Affairs and MedTech training opportunities here » (Swedish only)

 

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