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Regulatory Affairs Consulting for medical devices

 

Powers Regulatory Consulting is a medical device regulatory consulting firm that can be an extension of your organization to help with any regulatory needs.  Consulting with regulatory early will help make a more efficient and predictable product development process.  Powers Regulatory Consulting can provide valuable expertise and insight into the regulatory process. 

 

REGULATORY STRATEGY

A regulatory strategy early in the development process is critical to efficiently move a medical device through product development.  

  • When should we talk to the FDA?

  • Do you need an FDA submission? An EU submission?  

  • Do you need a clinical study?

  • What is the classification of my device in the US and Europe?

Powers Regulatory Consulting can complete an initial regulatory strategy and assessment can answer these questions.  

REGULATORY PRE-MARKET SUBMISSIONS

Powers Regulatory Consulting can help with all types of pre- and post-market regulatory submissions and requirements including: 

  • 510(k)- Traditional, Abbreviated or Special 

  • 513(g)- Request for designation

  • Pre-Submissions (Pre-IDE, Pre-510(k), etc)

  • Investigational Device Exemption (IDE), supplements and annual reports

  • Pre-Market Approval (PMA), supplements and annual reports

  • PMA Real Time Review and 30 Day Notices

  • European Technical File and Design Dossiers for MDD, AIMD and MDR

  • International Dossiers 

  • QC/QA of regulatory submissions

REGULATORY POST- MARKET ACTIVITIES

Even after there is a device clearance or approval, there are many post-market requirements.  

  • Annual Reports

  • Device modification evaluations (note to file)

  • Change management for Class I, II and III devices

  • Change notification to notified body

  • Technical File audits 

  • Dossier lifecycle management

REGULATORY SERVICES

Regulatory is more than the submissions and strategies.  Other service offerings include: 

  • eCopy production

  • Instructions for Use Writing

  • Labeling Review 

  • Promotional and advertising materials review 

  • Clinical Evaluation Reports- new, updates or reviews

  • Establishment registration and device listings

  • Regulatory due diligence and integration

  • Regulatory project management 

  • Regulatory training

REGULATORY EXPERIENCE

Powers Regulatory Consulting has recent device experience in the following areas:  

  • USA Class 1, 2 and 3 products

  • EU Class I, IIa, IIb and III products

  • Cardiology

  • Vascular 

  • Urology

  • General surgery

  • Mobile medical apps

  • Wearable devices

  • Capital equipment with hardware/software

  • Implantable products

  • Home use products

©2020 by Powers Regulatory Consulting