WANT TO BE AMONG THE MOST TRUSTED AND EFFECTIVE
MEDICAL DEVICE COMPANIES?

Your expertise paired with our medical device consulting services
result in customized solutions that meet FDA regulations as well as
requirements necessary to help your device reach global markets.

DOES YOUR COMPANY HAVE REGULATORY GUIDANCE NECESSARY TO
MAINTAIN QUALITY ASSURANCE
AND
AN EXCELLENT CUSTOMER EXPERIENCE OF YOUR MEDICAL DEVICE
ALL WHILE BUILDING A
FISCALLY RESPONSIBLE BUSINESS THAT HAS
CONSISTENT PERFORMANCE METRICS?

DP Distribution & Consulting® assists clients to:
-increase efficiencies and ensure continuous improvement
-implement an effective quality management system
-navigate regulatory compliance and
-consistently achieve excellent patient outcomes.
Whether your team needs to make an FDA submission, run clinical trials, or plan for your
device's entire product lifecycle, DP regulatory consultants can help ensure that your
risk management processes and regulatory strategies help you become a
go-to medical device manufacturer within your company's budget.

Are you navigating the challenges of your medical device's
regulatory landscape?

We can help you make sense of the medical device industry.
We'll implement effective quality systems for your business and your people.
Choose the medical device regulatory consulting experts that will help you thrive.

50+

YEARS OF EXPERIENCE

210+

CLIENTS HELPED

175+

FDA AUDITS

330+

ISO 9001/13485 AUDITS

615+

INTERNAL AUDITS

KEY SERVICES

DP Distribution & Consulting ®, LLC, medical device consulting specializes in:

Quality Management Systems
NIOSH Submissions for N95 Respirators
Independent Third-Party Assessments (FDA/QSR, ISO 13485, ISO 9001)
510(k)s for Medical Devices
Training (QSR, QSIT, CAPA, etc. – On- or Off-Site)
Process Validation Programs
Sterilization Expertise and Services
Support for Start Up Medical Device Manufacturers

HOW IT WORKS