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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. 

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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 MDR submission?

  • What testing is required?

  • 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.  



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 (Q-Subs, Pre-IDE, Pre-510(k), Submission Issue, Significant Risk, etc.)

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

  • Pre-Market Approval (PMA), Supplements, Real Time
    Reviews, 30 day notices and Annual Reports

  • European Technical Documentation (MDR) 

  • International Dossiers 

  • QC/QA of regulatory submissions

Services: Service


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

  • Orthopedic 

  • General surgery

  • Mobile medical apps, Software as a Medical Device (SaMD)

  • Wearable devices

  • Capital equipment with hardware/software

  • Implantable products

  • Home use products


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 

  • Establishment registration and device listings

  • Regulatory due diligence and integration

  • Regulatory project management 

  • Regulatory training



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

  • Regulatory Change Assessments including Letters
    to File

  • Annual Reports

  • Change management for USA and EU Class I, II and III devices

  • PMA Supplements, Real Time Review Supplements, 30 day change notices

  • Change notification to notified body

  • Technical File audits 

  • Dossier lifecycle management


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