Regulatory

Can your company keep up with the changing regulatory landscape?

Medical devices and Pharmaceuticals play a vital role in the advancement of patient care from imaging, neurostimulators, orthopedics, medical software, wound care, and everything in-between. Navigating the approval process for health care products is a critical aspect of product development and can be uncharted territory. RISQ Management understands the approval process 'inside out', and how to tailor the process for your project. ​​

We are here to help our clients with technical dossiers and developmental plans, we can provide research and interpretation of regulations, provide clear direction of regulatory status. We’re here to help you succeed!

 

The services provided a RISQ Management encompasses total life cycle of Marketing Application Support ( BLA, 510(k), PMA, Combination Products, etc.). that means no matter where you are in your project pre- or post- market we are here to help:

  • PMA

  • 510k

  • BLA

  • Design Dossier/technical files for CE Mark

  • Post Market Support

  • MRI Safety of Products

  • Label Development/Expansion

  • Clinical trial applications and notifications 

  • Pre-submission review of technical documents

  • ISO 13485

  • Development of new CER's and updating of existing CER's

  • Literature reviews

  • Software as a Medical Device

  • Annual and Final Report Writing

  • Critical writing and review of documentation

  • Assist or Represent clients in interactions with FDA/Notified Body

  • Provide clients with expert review of submissions

  • Advise on regulatory strategy and potential submission pathways

  • Custom reporting activities to ensure compliance with all applicable global regulations

Working with RISQ Management means working with a consultancy partnership founded on the principle that better healthcare holds the promise of a better future for patients. RISQ Management will be the partner you need to help guide through the ever-evolving regulatory landscape. When you work with RISQ Management, an experienced subject-matter expert is always readily available.

 

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