MCRA
MCRA, LLC
MCRA is a leading medical device and MedTech Contract Research Organization (CRO) and consulting advisory firm specializing in regulatory, quality, clinical, and reimbursement services. MCRA offers comprehensive biocompatibility testing support and strategic guidance for medical device manufacturers navigating FDA, EU MDR, and global regulatory requirements.
MCRA is a premier medical device and MedTech Contract Research Organization (CRO) and consulting advisory firm that provides integrated regulatory, quality, clinical, and reimbursement services. With deep expertise in biocompatibility testing and ISO 10993 compliance, MCRA helps medical device manufacturers navigate complex regulatory pathways including FDA 510(k), PMA, EU MDR, and international submissions. The firm offers strategic consulting on biocompatibility testing strategies, test plan development, and regulatory submission support. MCRA's team of experienced regulatory professionals works closely with clients to ensure efficient and compliant biocompatibility programs that meet global regulatory standards.
About
**Who they are**
MCRA is a leading medical device and MedTech Contract Research Organization (CRO) and consulting advisory firm specializing in regulatory, quality, clinical, and reimbursement services. They offer comprehensive biocompatibility testing support and strategic guidance for medical device manufacturers navigating FDA, EU MDR, and global regulatory requirements.
**Expertise & scope**
* Integrated services encompassing clinical research, regulatory affairs, reimbursement, compliance, and specialized therapy expertise.
* Guidance through the entire medical device lifecycle, from pre-clinical testing to post-commercialization.
* Expertise in FDA regulatory consulting, including PMA and 510(k) submissions, with a strong track record.
* Specialized services in AI & Imaging Center for radiologic AI/ML enabled medical devices, including study design and regulatory guidance.
* Statistical analysis for medical devices, with a team including former senior FDA statisticians.
* Cybersecurity solutions for medical devices, including risk assessments and strategy.
* Global regulatory consulting across major markets such as 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 worldwide.
* Unparalleled PMA track record, including first Orthopedic and Spine De Novo grants.
* Multiple FDA appeal achievements and numerous challenging 510(k) clearances.
* Extensive therapeutic expertise across a wide range of clinical focus areas.
MCRA is a leading medical device and MedTech Contract Research Organization (CRO) and consulting advisory firm specializing in regulatory, quality, clinical, and reimbursement services. They offer comprehensive biocompatibility testing support and strategic guidance for medical device manufacturers navigating FDA, EU MDR, and global regulatory requirements.
**Expertise & scope**
* Integrated services encompassing clinical research, regulatory affairs, reimbursement, compliance, and specialized therapy expertise.
* Guidance through the entire medical device lifecycle, from pre-clinical testing to post-commercialization.
* Expertise in FDA regulatory consulting, including PMA and 510(k) submissions, with a strong track record.
* Specialized services in AI & Imaging Center for radiologic AI/ML enabled medical devices, including study design and regulatory guidance.
* Statistical analysis for medical devices, with a team including former senior FDA statisticians.
* Cybersecurity solutions for medical devices, including risk assessments and strategy.
* Global regulatory consulting across major markets such as 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 worldwide.
* Unparalleled PMA track record, including first Orthopedic and Spine De Novo grants.
* Multiple FDA appeal achievements and numerous challenging 510(k) clearances.
* Extensive therapeutic expertise across a wide range of clinical focus areas.
Additional information
MCRA emphasizes an integrated approach, combining regulatory, clinical, reimbursement, and quality assurance services to streamline the medical device product lifecycle. This holistic strategy aims to accelerate market access and commercialization by leveraging expertise across various domains, including biocompatibility, statistics, and cybersecurity. Their team comprises former regulatory agency experts, including FDA assistant directors, branch chiefs, and reviewers, alongside seasoned industry professionals with extensive experience in medical device regulations and product development. This deep bench of talent allows MCRA to provide tailored strategies for navigating complex global regulatory landscapes and achieving successful market entry and sustained compliance.
Key Highlights
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MCRA offers comprehensive biocompatibility testing support and strategic guidance for medical device manufacturers.
Source
“MCRA offers comprehensive biocompatibility testing support and strategic guidance for medical device manufacturers navigating FDA, EU MDR, and global regulatory requirements.”
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The organization has a strong track record with FDA submissions, including PMA and 510(k) clearances.
Source
“Unparalleled PMA track record- 1st Orthopedic and 1st Spine De Novo grant- Multiple FDA appeal achievements- Countless 510(k) clearances, many include industries most challenging”
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MCRA provides integrated services across regulatory, clinical, reimbursement, and quality assurance.
Source
“MCRA is the first medical device regulatory consulting company to integrate expert services within a team of regulatory subject matter experts, creating the partner of choice in clinical, regulatory, reimbursement, quality assurance, compliance, and expert services such as biocompatibility, statistics, usability, cybersecurity.”
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The firm has a global presence with offices in North America and Asia.
Source
“We have offices in New York City, Washington, D.C., Hartford, CT, and Tokyo, making us a global leader in this space with more than 1,000 clients around the world.”
Certifications & Trust Signals
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Over 150 years of combined experience within the organization.
Source
“With more than 150 years of combined experience within our organization, we stand as the leading privately held diagnostics, biologics and medical device CRO and advisory firm.”
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Serves over 1,000 clients worldwide.
Source
“We have offices in New York City, Washington, D.C., Hartford, CT, and Tokyo, making us a global leader in this space with more than 1,000 clients around the world.”
Buyer Snapshot
Best for
- Medical device and MedTech companies seeking comprehensive regulatory and clinical support.
- Manufacturers navigating complex global regulatory requirements (FDA, EU MDR, etc.).
- Companies needing specialized expertise in areas like AI/ML medical devices, cybersecurity, and statistical analysis.
How engagement typically works
- Collaborative, working hand-in-hand as part of the client's team.
- Integrated service model across regulatory, clinical, reimbursement, and quality assurance.
- Strategic guidance throughout the entire product lifecycle.
Typical deliverables
- Regulatory submission strategies and support (PMA, 510(k), De Novo).
- Clinical trial design, execution, and management.
- Reimbursement and market access strategies.
- Biocompatibility testing guidance and support.
- AI/ML medical device regulatory consulting.
- Cybersecurity risk assessments and strategy.
Good to know
- Best when requiring a full-spectrum CRO and advisory firm for medical device development and commercialization.
HQ:
New York City, United States
Languages:
English
Timezones:
UTC, EST
Claim status:
Listed
Services & Capabilities
Biocompatibility Testing (ISO 10993 Program)
Countries:
United States, United Kingdom, Canada, Japan, Europe, Asia
Industries:
Medical Devices
Pricing model:
Custom pricing
Iso10993 Standards Supported:
ISO 10993-1, Other
Test Types Offered:
Systemic toxicity, Genotoxicity, Carcinogenicity, Reproductive toxicity, Biodegradation, Other
Glp Compliant:
Yes
Has In House Toxicology:
Yes
Contact Types Supported:
Surface contact, External communicating, Implant
Duration Types Supported:
Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)
Is Accredited:
Yes
Toxicology Capabilities:
MCRA's toxicology and biocompatibility team are experts in providing toxicity services, including toxicological risk assessments. They employ state of the art methodologies to their toxicological evaluation and utilize your full biocompatibility package to provide a robust package for regulatory submission. They have extensive knowledge and experience in developing benefit-risk assessments for the EU MDR, including for substances classified as Class 1A and 1B carcinogenic, mutagenic, or toxic for reproduction (CMR substances).
Lead Time Band:
Start in 2-4 weeks
Quote SLA:
3-5 business days
Rush Available:
Yes
Regions Served:
United States, Europe, Asia
Additional biocompatibility_testing Details
Iso10993 Standards Supported
ISO 10993
Test Types Offered
Biocompatibility testing
Contact Types Supported
Surface contact, External communicating, Implant
Duration Types Supported
Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)
Lead Time Band
Start in 0-2 weeks
Quote SLA
3-5 business days
Pricing Model
Custom
