top of page

What's your next move?

Regulatory Affairs Consulting for medical devices

Home: Welcome

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. 

Home: Service
Coffee and Magazines


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?  

  • 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 (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 Documentation for MDR and transition from MDD and AIMDD.

  • QC/QA of regulatory submissions

  • eCopy and eSTAR for FDA



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

  • Annual Reports

  • Device modification evaluations (letter to file)

  • Change management for Class I, II and III devices

  • Change notification to notified body

  • Technical Documentation audits 

  • Dossier lifecycle management



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

  • eCopy and eSTAR 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



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

  • General Wellness Device

  • Clinician Decision Support Software

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

  • Wearable devices

  • Capital equipment with hardware/software

  • Implantable products

  • Home use products

bottom of page