What's your next move?
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 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.
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 Documentation for MDR and transition from MDD and AIMDD.
-
QC/QA of regulatory submissions
-
eCopy and eSTAR for FDA
REGULATORY POST- MARKET ACTIVITIES
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 SERVICES
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
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
-
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