DP Distribution & Consulting
DP Distribution & Consulting LLC is a family-owned company with over 22 years of experience in medical device regulatory consulting. They specialize in helping medical device companies navigate FDA regulations, implement quality systems, and achieve compliance to reach global markets. Their mission is to ensure compliance and maximize profits for their clients through expert guidance in regulatory affairs, quality management, and industry standards.
Industries
Nr. of Employees
small (1-50)
DP Distribution & Consulting
Rockville, Virginia, United States, North America
Services
Gap assessments and implementation support for QSR/QMSR, ISO 13485 and ISO 9001 quality systems, including CAPA and internal audits.
Assistance with establishment registration, annual renewals, device listing and serving as U.S. agent for non‑US manufacturers.
Preparation and review of 510(k) submissions and other premarket submissions (PMA, IDE, De Novo, Q-Sub) to support regulatory clearance or approval.
Development of sterilization protocols and validation for EtO, gamma and e-beam processes and guidance on aseptic processing.
Services to assess gaps, plan conversions and implement processes to achieve ISO 13485 compliance.
Regulatory guidance for manufacturing masks, gowns and other PPE as medical devices and assistance with NIOSH respirator approval applications.
Gap assessments and implementation support for QSR/QMSR, ISO 13485 and ISO 9001 quality systems, including CAPA and internal audits.
Assistance with establishment registration, annual renewals, device listing and serving as U.S. agent for non‑US manufacturers.
Preparation and review of 510(k) submissions and other premarket submissions (PMA, IDE, De Novo, Q-Sub) to support regulatory clearance or approval.
Development of sterilization protocols and validation for EtO, gamma and e-beam processes and guidance on aseptic processing.
Services to assess gaps, plan conversions and implement processes to achieve ISO 13485 compliance.
Regulatory guidance for manufacturing masks, gowns and other PPE as medical devices and assistance with NIOSH respirator approval applications.
Expertise Areas
- Medical device regulatory compliance (FDA and international)
- Quality management systems (QSR/QMSR and ISO 13485)
- Sterilization methods and validation
- Regulatory submission strategy and preparation (510(k)/PMA/IDE/De Novo)
Key Technologies
- FDA QSR / QMSR requirements
- ISO 13485 quality management standard
- 510(k) / PMA / IDE / De Novo regulatory pathways
- NIOSH respirator approval process
News & Updates
Discussion on the FDA's move to harmonize the Quality System Regulation (21 CFR Part 820) with ISO 13485, aiming for lower costs and greater efficiencies.
The European Commission has proposed modifications to some of the dates for the IVDR implementation due to COVID-19 impacts.
The FDA proposes a program requiring manufacturers of critical devices to notify the FDA if production levels are lower than planned to prevent shortages.
Discussion on the FDA's move to harmonize the Quality System Regulation (21 CFR Part 820) with ISO 13485.
The article discusses how inexpensive Chinese masks are impacting US mask manufacturers, leading to layoffs and closures.
Details on the FDA's efforts to align its Quality System Regulation with international standards.
Discussion on the FDA's move to harmonize the Quality System Regulation (21 CFR Part 820) with ISO 13485, aiming for lower costs and greater efficiencies.
The European Commission has proposed modifications to some of the dates for the IVDR implementation due to COVID-19 impacts.
The FDA proposes a program requiring manufacturers of critical devices to notify the FDA if production levels are lower than planned to prevent shortages.
Discussion on the FDA's move to harmonize the Quality System Regulation (21 CFR Part 820) with ISO 13485.
The article discusses how inexpensive Chinese masks are impacting US mask manufacturers, leading to layoffs and closures.
Details on the FDA's efforts to align its Quality System Regulation with international standards.