Providing Regulatory Services for Innovative Medical Products
Headquartered in Phoenix, Arizona, Wolf Regulatory Consulting specializes in supporting innovative medical device designers and manufacturers across the western United States and throughout the world. We provide medical device product registration strategies and author technically-oriented registration submissions for the US, EU, and various other global markets. Whether you're a physician, startup, or established medical device manufacturer, we have the depth of regulatory expertise necessary to take your product to market and position it for long-term success.
Use the form at the bottom of this page, or the contact information provided, to schedule an initial consultation. We look forward to exploring whether our services are right for you.
Contact
➤ Mail Correspondence
PO Box 45404
Phoenix, AZ 85064
inquiries@wolfregulatory.com
☎ Telephone
(503) 840-5849
“Great things are done by a series of small things brought together”
Key Services
Strategies & Roadmaps
Regulatory intelligence: analyzing and synthesizing existing and emerging requirements to create and manage an efficient regulatory roadmap for a specific indication, product, market, or company. At Wolf Regulatory Consulting, that is what we consider our greatest strength and the cornerstone of our expertise. We're specialized in developing global strategies that align with the strengths and constraints of a given project. We can help you develop a strategy that leverages regulatory requirements and review timelines to optimize your product launch. We can collaborate to determine the verification and validation strategies, protocols, and prioritizations that address your the particular regulatory needs while conforming to your project plan.
US & EU Device Registration
Applications for product registration must be thorough, persuasive, and technically accurate. At Wolf Regulatory Consulting, we have the unique blend of skills necessary to author a balanced, successful application. We have authored numerous 510(k)s and Technical Files, and are well-versed with less common approaches such as IDEs and the De Novo Classification Process. We also recognize that obtaining product approval or clearance isn't itself sufficient; it needs to be the right approval. Our experience includes Requests for Designation, 513(g) Requests for Information, 510(k) Exemption rationales, and significant change assessments (K97-1), so you can rest assured that your product will launch with appropriate approvals and optimized indications.
Clinical Outcomes Analysis
Clinical outcomes and efficacy analysis is rapidly emerging as a crucial component of registrations and renewals. Wolf Regulatory has allocated significant time to honing clinical data analysis skills, developing particular proficiency in generating MEDDEV 2.7/1 revision 4-compliant Clinical Evaluation Reports for Notified Bodies. We are also experienced in assisting with related clinical assessment activities, such as: Risk Management Report (RMR) assessment, complaints dispositioning, Health Hazard Evaluations (HHEs) and related recall assessments. Regulatory requirements don't disappear once your product is launched, but working together we can help ensure sustained success.
Let's Chat.
Use the form below to contact us regarding your inquiry, and we’ll call you back to schedule an appointment. You may also email or call us to make an appointment. Our general response time is one business day.