Medical Device Regulatory Consulting
Expert consulting services to take your business to the next level
About Device Pathways
Our Approach
At Device Pathways LLC, we take a holistic approach to consulting. We work closely with our clients to understand their goals and challenges and develop solutions that address their specific needs. Our approach is collaborative, transparent, and results-driven.
Our Services
QA/RA consulting:
Leverage my expertise to solve complex regulatory challenges. I will design a regulatory and QMS strategy that takes your product to established and emerging markets.
- Medical device classification determination and assessments
- Navigate complex medical device regulatory requirements.
- QMS compliance in medical device markets- ISO 13485:2016, MDSAP (Medical Device Single Audit Program)
Medical Device Registration:
Depending on where you plan to sell your device(s), successful registration may involve a substantial effort to meet premarket technical and clinical submission requirements or leveraging your existing registrations and approvals to gain faster access to new markets. Device registration requirements can vary significantly from country to country, which can create compliance challenges for companies pursuing multiple-market strategies. I can compile, submit, and manage all your device registrations.
- USA
- FDA Regulatory and Quality Support: 510(k), PMA, Q-Submission meetings, IDE, de novo, Breakthrough designation,
- Europe:
- Technical documentation creation and Notified body AI responses
- EU MDR compliance- creation and use of templates, tools, and audit checklist to cover EU MDR compliance
- Clinical evaluation reports
- PMS reports
- Canada
- Establishment Registration
- Medical device License Application and registration
Our Team
Sanjay Shah, founder and principal consultant at Device Pathways LLC, is a seasoned Regulatory Affairs professional with over 30 years of experience in the medical device industry. Throughout his career, Sanjay has worked for several different medical device companies (Medtronic, Imris, Deerfield Imaging, Laborie,..), each specializing in a unique area of healthcare technology. This diverse experience has provided him with a deep and broad understanding of the regulatory landscape, as well as invaluable expertise in navigating the distinct challenges posed by various medical devices.
Contact Us
Better yet, see us in person!
We love our customers, so feel free to visit during normal business hours.
devicepathways@outlook.com
Hours
Today | Closed |
