MCRA
MCRA – Expert FDA Regulatory Consulting for Medical Devices
MCRA is a dedicated FDA regulatory consulting firm specializing in supporting medical device companies. With extensive expertise, they offer comprehensive guidance and implementation strategies for a wide range of FDA submissions, ensuring clients navigate the regulatory landscape effectively.
About
**Who they are**
MCRA is a leading U.S. Regulatory Advisor for the Medical Device and Biologics industries, offering integrated services across the product lifecycle. With a deep bench of FDA consultants and over 150 years of combined experience within their organization, they act as a strategic partner for companies navigating complex regulatory landscapes.
**Expertise & scope**
* Comprehensive clinical research services, including pre-clinical testing, regulatory submission, market approval, and post-commercialization support.
* Expert FDA regulatory consulting for medical devices and biologics, with a strong track record in PMA, De Novo, and 510(k) submissions.
* Medical device reimbursement, health economics, and market access services to guide commercialization strategies.
* Specialized services for AI/ML-enabled medical devices, including study design and regulatory guidance from former FDA reviewers.
* Statistical analysis for medical devices, with a team including former senior FDA statisticians to ensure data integrity and presentation for regulatory bodies.
* Cybersecurity solutions for medical devices and Software as a Medical Device (SaMD) to protect client and patient information.
* Global regulatory consulting across major markets including the US, EU, UK, Japan, and Canada.
**Reputation / proof points**
* Over 150 years of combined experience within the organization.
* Offices in New York City, Washington, D.C., Hartford, CT, and Tokyo.
* More than 1,000 clients around the world.
* Accomplishments include a strong PMA track record, first Orthopedic and Spine De Novo grants, multiple FDA appeal achievements, and numerous challenging 510(k) clearances.
MCRA is a leading U.S. Regulatory Advisor for the Medical Device and Biologics industries, offering integrated services across the product lifecycle. With a deep bench of FDA consultants and over 150 years of combined experience within their organization, they act as a strategic partner for companies navigating complex regulatory landscapes.
**Expertise & scope**
* Comprehensive clinical research services, including pre-clinical testing, regulatory submission, market approval, and post-commercialization support.
* Expert FDA regulatory consulting for medical devices and biologics, with a strong track record in PMA, De Novo, and 510(k) submissions.
* Medical device reimbursement, health economics, and market access services to guide commercialization strategies.
* Specialized services for AI/ML-enabled medical devices, including study design and regulatory guidance from former FDA reviewers.
* Statistical analysis for medical devices, with a team including former senior FDA statisticians to ensure data integrity and presentation for regulatory bodies.
* Cybersecurity solutions for medical devices and Software as a Medical Device (SaMD) to protect client and patient information.
* Global regulatory consulting across major markets including the US, EU, UK, Japan, and Canada.
**Reputation / proof points**
* Over 150 years of combined experience within the organization.
* Offices in New York City, Washington, D.C., Hartford, CT, and Tokyo.
* More than 1,000 clients around the world.
* Accomplishments include a strong PMA track record, first Orthopedic and Spine De Novo grants, multiple FDA appeal achievements, and numerous challenging 510(k) clearances.
Additional information
MCRA emphasizes an integrated approach, combining clinical research, regulatory affairs, reimbursement, compliance, and specialized therapy expertise. This holistic model aims to streamline the medical device lifecycle from concept to post-market. Their team includes former regulatory agency personnel, bringing valuable insights into agency expectations. Engaging MCRA can help mitigate risks and accelerate market access by aligning clinical evidence and regulatory strategies from the outset. They support clients of all sizes, from startups to established companies, in navigating both US and global regulatory requirements.
Key Highlights
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MCRA has been streamlining clinical trials for nearly 20 years, advising across every stage of the process.
Source
“MCRA has been streamlining the effectiveness and success of clinical trials for nearly 20 years, advising across every stage of the process”
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Their FDA medical device consulting team includes former CDRH Branch Chief Glenn Stiegman with over 18 years of experience.
Source
“The team is led by former CDRH Branch Chief, Glenn Stiegman, who has over 18 years of experience working in medical device regulation.”
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MCRA's AI & Imaging Center is led by former FDA experts and is built specifically for AI/ML-enabled medical devices in radiology.
Source
“Led by former FDA experts and powered by a global network of imaging and clinical professionals, we are the only integrated solution built specifically for AI/ML-enabled medical devices in radiology.”
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Their statistical team includes former senior FDA statisticians well-versed in FDA submission requirements.
Source
“Our team includes former senior FDA statisticians who are well-versed in the requirements needed for FDA submissions”
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MCRA's Regulatory Team has an unprecedented success rate for PMAs, 510(k)s, breakthrough designations, and CE mark applications.
Source
“MCRA’s Regulatory Team has an unprecedented success rate for PMA’s, 510(k)s, breakthrough designations, and CE mark applications”
Certifications & Trust Signals
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MCRA is the leading U.S. Regulatory Advisor for the Medical Device and Biologics industries.
Source
“MCRA is the leading U.S. Regulatory Advisor for the Medical Device and Biologics industries.”
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They have offices in New York City, Washington, D.C., Hartford, CT, and Tokyo, positioning them as a global leader.
Source
“We have offices in New York City, Washington, D.C., Hartford, CT, and Tokyo, making us a global leader in this space”
Buyer Snapshot
Best for
- Medical device and biologics companies seeking end-to-end regulatory and clinical support.
- Innovators in AI/ML-enabled medical devices requiring specialized regulatory guidance.
- Companies pursuing global market entry for their medical technologies.
How engagement typically works
- Collaborative, acting as an extension of the client's team.
- Integrated service delivery across multiple functional areas.
- Data-driven strategy development and execution.
Typical deliverables
- FDA submission strategy and authoring (510(k), De Novo, PMA).
- Clinical trial design, execution, and management.
- Reimbursement and market access strategies.
- Cybersecurity assessments and strategy.
- Global regulatory compliance plans.
Good to know
- Best when a comprehensive, integrated approach to product development and market access is required.
HQ:
Washington D.C., US
Languages:
English
Timezones:
UTC, EST
Claim status:
Listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, 510(k) Strategy & Authoring, Medical Device Reimbursement, De Novo Strategy & Authoring, PMA Strategy & Support, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C), Submission Project Management (end-to-end)
Pathways Supported:
Traditional 510(k), Special 510(k), Abbreviated 510(k), De Novo, PMA, Pre-Sub / Q-Sub
Device Types Supported:
Medical device, IVD, Combination product
Supports Rta Remediation:
No
Supports Predicate Research:
Yes
Years Experience:
18
Num510k Submitted:
100000
Ex FDA:
Yes
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
Orthopedics, Digital Imaging, Neuro-musculoskeletal, Radiology
Technology Types:
AI/ML enabled medical devices, Radiologic AI tools, Medical imaging
Accepting New Clients:
Yes
Supports Estar:
No
Supports Labeling Review:
No
Provides Submission Project Management:
Yes
Engagement Models:
Full-service, Component-based
