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.