Medical Device
Regulatory Affairs
Services

Medical Device – Regulatory

Regulations can be an overwhelming hurdle when moving your product through the medical device industry. That’s where Network Regulatory Partners comes in. We’ve designed our business to provide the right amount of support at the right time —helping clients through all the important and difficult parts of bringing a product to market and staying compliant.

Submission Preparation

Medical Device regulatory experts support common, and uncommon global submissions.

  • US Regulatory submissions (510(k), PMA, 180 Day, 30 day Notices, RTR, IDE, Compassionate Use, HUD, HDE, CFG)
  • International STED development
  • Health Canada license amendments
  • EU technical files, design dossiers, CE renewals and change notifications
  • ROW market support

Post Market &
Regulatory Agency Support

Our team utilizes their medical device industry experience and executes regulatory post-market strategies in a cost effective and compliant manner.

  • FDA-483 and warning letter responses
  • Consent decrees
  • Recall support
  • Liaison between company and regulatory agencies
  • US agent services & establishment registrations
  • Preparation of internal team for agency meetings

CERs

  • Writing Clinical Evaluation Plans (CEPs)
  • Updating existing CERs for compliance with MEDDEV Rev. 4 & EU MDR
  • Writing pre-market CERs compliant with MEDDEV Rev. 4 & EU MDR
  • Writing Post Market Clinical Follow Up (PMCF) plans
  • Clinical evaluators for various therapeutic areas
  • State-of-the-art justification
  • Literature searches, weighting and summarization

EU MDR/IVDR Support

  • Overall EU MDR/IVDR compliance strategy
  • Change in Notified Bodies
  • Labeling review and updates
  • Technical documentation gap assessment and remediation
  • Design dossiers and renewals
  • CER and PER writing and review
  • Post marketing surveillance/follow-up plan development
  • EUDAMED database management
  • EU UDI implementation
  • Assess and verify economic operator responsibilities are aligned with new requirements
  • Perform staff training on MDR/IVDR implementation

Regulatory Strategy Development

Network Partners offers a comprehensive approach for regulatory strategy development.

  • Gap analysis of existing documentation
  • Regulatory strategy & Project deliverables US/EU/CA/ROW
  • Marketing strategy support
  • Due diligence

 
 
 

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