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**
* Provides comprehensive biocompatibility testing support and strategic guidance.
* Navigates FDA, EU MDR, and global regulatory requirements for medical device manufacturers.
* Offers integrated services including clinical research, regulatory affairs, reimbursement, quality assurance, compliance, and expert services such as biocompatibility, statistics, and cybersecurity.
* Specializes in FDA regulatory consulting for medical devices, with expertise in PMA, 510(k) clearances, and breakthrough designations.
* Provides global regulatory consulting for medical devices and in vitro diagnostic devices, covering markets in the US, EU, UK, Japan, Canada, and Australia.
* Offers AI & Imaging Center services for radiologic AI/ML-enabled medical devices, including study design and regulatory guidance.
* Provides statistical analysis for medical devices, with statisticians integrated across service and therapy areas.
* Delivers cybersecurity solutions for medical devices and Software as a Medical Device (SaMD).
**Reputation / proof points**
* Over 150 years of combined experience within the organization.
* More than 1,000 clients worldwide.
* Offices in New York City, Washington, D.C., Hartford, CT, and Tokyo.
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**
* Provides comprehensive biocompatibility testing support and strategic guidance.
* Navigates FDA, EU MDR, and global regulatory requirements for medical device manufacturers.
* Offers integrated services including clinical research, regulatory affairs, reimbursement, quality assurance, compliance, and expert services such as biocompatibility, statistics, and cybersecurity.
* Specializes in FDA regulatory consulting for medical devices, with expertise in PMA, 510(k) clearances, and breakthrough designations.
* Provides global regulatory consulting for medical devices and in vitro diagnostic devices, covering markets in the US, EU, UK, Japan, Canada, and Australia.
* Offers AI & Imaging Center services for radiologic AI/ML-enabled medical devices, including study design and regulatory guidance.
* Provides statistical analysis for medical devices, with statisticians integrated across service and therapy areas.
* Delivers cybersecurity solutions for medical devices and Software as a Medical Device (SaMD).
**Reputation / proof points**
* Over 150 years of combined experience within the organization.
* More than 1,000 clients worldwide.
* Offices in New York City, Washington, D.C., Hartford, CT, and Tokyo.
Additional information
MCRA's integrated approach to medical device development emphasizes collaboration across regulatory, clinical, reimbursement, and quality assurance departments. This holistic strategy aims to streamline the product lifecycle from pre-clinical testing through post-market surveillance. Their team includes former FDA reviewers and regulatory agency personnel, bringing a deep understanding of regulatory expectations. They focus on providing strategic guidance to help clients achieve market access and commercialization efficiently, leveraging their expertise in various global markets and regulatory frameworks.
Key Highlights
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MCRA is a leading medical device and MedTech Contract Research Organization (CRO) and consulting advisory firm.
Source
“MCRA is a leading medical device and MedTech Contract Research Organization (CRO) and consulting advisory firm specializing in regulatory, quality, clinical, and reimbursement services.”
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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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Possesses deep expertise in FDA regulatory consulting, with a strong track record in PMA submissions and 510(k) clearances.
Source
“MCRA's FDA medical device consulting team is the most talented and experienced medical device and biologics team worldwide. Accomplishments include: Unparalleled PMA track record- 1st Orthopedic and 1st Spine De Novo grant- Multiple FDA appeal achievements- Countless 510(k) clearances”
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Provides global regulatory consulting services across major markets including the US, EU, UK, Japan, and Canada.
Source
“MCRA delivers integrated, region-specific regulatory strategies that help you enter global markets faster and stay compliant throughout your product’s lifecycle. From the US, EU, and UK to Canada, Japan, Australia, and beyond, we navigate complex regulations for medical devices and in vitro diagnostics”
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.”
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Team includes former FDA assistant directors, branch chiefs, team leads, and reviewers.
Source
“MCRA’s team includes former FDA assistant directors, branch chiefs, team leads and reviewers, former senior Notified Body reviewers, and 50+ veteran medical device experts with over 15 years’ experience.”
Buyer Snapshot
Best for
- Medical device manufacturers seeking comprehensive regulatory and clinical support.
- Companies navigating complex global regulatory pathways.
- Innovators in AI/ML-enabled medical devices requiring specialized study design.
How engagement typically works
- Collaborative, working as part of the client's team.
- Integrated service offering across multiple disciplines.
- Strategic guidance and implementation support.
Typical deliverables
- Regulatory submission strategies and support (PMA, 510(k), CE Mark).
- Clinical trial design, execution, and management.
- Biocompatibility testing guidance and support.
- Reimbursement and market access strategies.
- Cybersecurity assessments and solutions.
Good to know
- Best when a full-spectrum regulatory and clinical partner is needed.
- Best when navigating multiple global markets simultaneously.
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, 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 specializes in comprehensive services to ensure your medical devices are biocompatible, empowering you to confidently bring safe and effective products to market. Their tailored approach to biocompatibility consulting considers the unique aspects of each medical device and conducting a thorough risk assessment that covers the entire lifecycle of your device. Their biocompatibility approach leverages their extensive experience with each regulator’s interpretation of the biocompatibility standards, unlocking more efficient testing strategies than can be developed by reading the standards in isolation. With a team of experienced biocompatibility scientists and toxicologists with past work experience at both FDA and Industry, they are well-versed in global biocompatibility requirements, evaluation of materials, manufacturing processes, and potential risks related to biological safety of medical devices. MCRA’s streamlined biocompatibility process saves time and strengthens your market position. They provide expertise on regulations, strategy development, compliance with standards, testing design, and toxicological risk assessments. They collaborate closely with you to develop a customized plan for biocompatibility testing, addressing knowledge gaps and providing a clear path to success. Their medical device biocompatibility expertise empowers you to make informed decisions, mitigate risks, and efficiently achieve regulatory compliance.
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
