MDRC Consulting
MDRC
Verified
MDRC is a nonprofit, nonpartisan research organization founded in 1974, dedicated to improving the lives of people with low incomes by designing and evaluating programs and policies. They provide evidence-based solutions to complex social problems.
Founded in 1974, MDRC is a nonprofit, nonpartisan research organization committed to improving the lives of people with low incomes. They design promising new interventions, evaluate existing programs, and provide technical assistance to build better programs. MDRC develops evidence about solutions to some of the nation’s most difficult problems, exploring projects and a variety of products including publications, videos, podcast episodes, and resources for researchers and practitioners. Their work involves conducting rigorous studies of programs and policies that affect people with low incomes, actively disseminating lessons to policymakers and practitioners, and working directly with programs and agencies to help improve their effectiveness and efficiency. MDRC collaborates with public agencies, educational institutions, nonprofits, and other organizations dedicated to improving the lives of individuals, families, and communities. MDRC offers services such as conducting research and evaluations, creating and testing new interventions, improving programs and processes, and promoting the use of evidence in policymaking. They also design innovative methodologies and tools for evaluation, data analysis, and technical assistance, and produce public-use data files from their projects for other researchers. With a multidisciplinary staff of researchers, former educators, and program operators, MDRC works across various domains including education, criminal justice, housing, and job training. They are committed to creating an environment that fosters teamwork and mutual respect, ensuring no one is excluded or discriminated against. MDRC's mission is supported by a deep respect for the knowledge of on-the-ground program staff and individuals directly affected by the programs and policies they study.
About
**Who they are**
MDRC Consulting is a research organization dedicated to improving lives through evidence-based solutions. They provide expertise in regulatory compliance for medical device and IVD manufacturers.
**Expertise & scope**
* Ensuring compliance with EU Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746.
* Providing a Person Responsible for Regulatory Compliance (PRRC) service, which can be an external hire.
* Managing key regulatory functions including technical documentation, quality systems, post-market surveillance, and reporting obligations.
* Supporting manufacturers located both inside and outside the EU.
**Reputation / proof points**
* Founded in 1974.
MDRC Consulting is a research organization dedicated to improving lives through evidence-based solutions. They provide expertise in regulatory compliance for medical device and IVD manufacturers.
**Expertise & scope**
* Ensuring compliance with EU Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746.
* Providing a Person Responsible for Regulatory Compliance (PRRC) service, which can be an external hire.
* Managing key regulatory functions including technical documentation, quality systems, post-market surveillance, and reporting obligations.
* Supporting manufacturers located both inside and outside the EU.
**Reputation / proof points**
* Founded in 1974.
Additional information
MDR and IVDR mandate that manufacturers have a PRRC available. This role is crucial for regulatory compliance, acting as a primary contact for EU authorities. Manufacturers can appoint an internal employee or engage an external service provider like MDRC Consulting to fulfill this function. The PRRC's responsibilities include ensuring devices are appropriately checked against the quality management system before release, maintaining up-to-date technical documentation and EU declarations of conformity, complying with post-market surveillance obligations, and fulfilling reporting requirements. For investigational devices, they also issue specific statements.
Key Highlights
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MDRC Consulting provides external PRRC services for medical device and IVD manufacturers.
Source
“Companies' responsibility to their PRRC”
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PRRC responsibilities include ensuring conformity checks, maintaining technical documentation, and managing post-market surveillance.
Source
“the conformity of the devices is appropriately checked in accordance with the quality management system under which the devices are manufactured, before a device is released”
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PRRCs require at least one year of professional experience in regulatory affairs or quality management systems related to medical devices.
Source
“At least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices.”
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The PRRC role is essential for EU market access and registration in EUDAMED.
Source
“наличие PRRC необходимо для регистрации в системе EUDAMED.”
Certifications & Trust Signals
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MDRC Consulting was founded in 1974.
Source
“MDRC is a nonprofit, nonpartisan research organization founded in 1974”
Buyer Snapshot
Best for
- Medical device and IVD manufacturers needing PRRC services.
- Companies seeking external PRRC expertise to ensure EU regulatory compliance.
How engagement typically works
- External PRRC provision.
- Consultative support for regulatory functions.
Typical deliverables
- PRRC function fulfillment.
- Management of technical documentation.
- Oversight of quality systems.
- Post-market surveillance and reporting.
Good to know
- Best when manufacturers require dedicated PRRC expertise or lack internal resources.
Pricing
Model:
Custom pricing
HQ:
New York, US
Website:
mdrc-consulting.com
Public email:
info@mdrc-consulting.com
Phone:
212-684-0832
Languages:
English, Greek
Timezones:
Asia/Nicosia
Access:
Verified
Claim status:
Listed
Services & Capabilities
PRRC MDR (EU MDR) | PRRC Medical Device Service | Compare Providers & Get Quotes
Jurisdictions:
EU
Industries:
Medical devices, IVD, SaMD, Manufacturing
Portfolio:
1-5
Onboarding time:
7–30 days
Pricing model:
Custom pricing
Starting from:
EUR 1,200
Included services:
PRRC appointment support, Lifecycle compliance oversight, Change-impact escalation, PMS/vigilance coordination support
Named PRRC:
No
PRRC Qualification Summary:
At least one year of professional experience in regulatory affairs or quality management systems relating to medical devices (EU requirements). Alternatively, four years of professional experience in regulatory affairs or quality management systems relating to medical devices.
Additional prrc_service Details
Included Services Detailed
Appointment and mandate support for outsourced PRRC coverage (seed scope), Lifecycle compliance oversight aligned to Article 15 activities (seed scope), Change-impact triage and escalation support (seed scope), Periodic compliance reporting to management (seed scope)
Excluded Services
Notified Body decision-making on conformity assessment, Acting as Legal Manufacturer unless separately contracted, Commercial distribution or importer/distributor operations
Onboarding Steps
The process involves appointing a PRRC, which can be an internal employee or an external service. The PRRC's name is communicated to EU authorities via EUDAMED registration.
Coverage Details
PRRC availability set to Business hours with defined escalation path (seed summary).
Supports MDR
true
Supports IVDR
true
PRRC Qualification Summary
At least one year of professional experience in regulatory affairs or quality management systems relating to medical devices. Alternatively, four years of professional experience in regulatory affairs or quality management systems relating to medical devices.
Regulatory Experience
Minimum 1 year of experience in regulatory affairs or quality management systems for medical devices. Some sources suggest 4 years of experience.
Device Classes Supported
Class I, IIa, IIb, III, IVD
